BIOMÉRIEUX

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VITEK® 2 GP

INTENDED USE
These Instructions for Use correspond to the VITEK® 2 Systems 7.01 and 8.01 software. If you are not using VITEK® 2
Systems 7.01 or 8.01 software, please refer to the VITEK® 2 Systems Product Information that you received with your current
software version.
The VITEK® 2 Gram-Positive identification card (GP) is intended for use with VITEK® 2 Systems for the automated
identification of most significant Gram-positive organisms. The VITEK® 2 GP identification card is a single-use disposable.
For a list of claimed species, see the Organisms Identified section.
DESCRIPTION
The GP identification card is based on established biochemical methods2,3,7,8,9,10,11,14,20,21,22,23,27,32,37,39 and newly
developed substrates. There are 43 biochemical tests measuring carbon source utilization, enzymatic activities and
resistance. Final identification results are available in approximately eight hours or less.
For a list of well contents, see the GP Well Contents table.

GP Well Contents

Well Test Mnemonic Amount/Well

2 D-AMYGDALIN AMY 0.1875 mg
4 PHOSPHATIDYLINOSITOL PHOSPHOLIPASE C PIPLC 0.015 mg
5 D-XYLOSE dXYL 0.3 mg
8 ARGININE DIHYDROLASE 1 ADH1 0.111 mg
9 BETA-GALACTOSIDASE BGAL 0.036 mg
11 ALPHA-GLUCOSIDASE AGLU 0.036 mg
13 Ala-Phe-Pro ARYLAMIDASE APPA 0.0384 mg
14 CYCLODEXTRIN CDEX 0.3 mg
15 L-Aspartate ARYLAMIDASE AspA 0.024 mg
16 BETA GALACTOPYRANOSIDASE BGAR 0.00204 mg
17 ALPHA-MANNOSIDASE AMAN 0.036 mg
19 PHOSPHATASE PHOS 0.0504 mg
20 Leucine ARYLAMIDASE LeuA 0.0234 mg
23 L-Proline ARYLAMIDASE ProA 0.0234 mg
24 BETA GLUCURONIDASE BGURr 0.0018 mg
25 ALPHA-GALACTOSIDASE AGAL 0.036 mg
26 L-Pyrrolydonyl-ARYLAMIDASE PyrA 0.018 mg
27 BETA-GLUCURONIDASE BGUR 0.0378 mg
28 Alanine ARYLAMIDASE AlaA 0.0216 mg
29 Tyrosine ARYLAMIDASE TyrA 0.0276 mg
30 D-SORBITOL dSOR 0.1875 mg
31 UREASE URE 0.15 mg
32 POLYMIXIN B RESISTANCE POLYB 0.00093 mg
37 D-GALACTOSE dGAL 0.3 mg

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Well Test Mnemonic Amount/Well

38 D-RIBOSE dRIB 0.3 mg
39 L-LACTATE alkalinization ILATk 0.15 mg
42 LACTOSE LAC 0.96 mg
44 N-ACETYL-D-GLUCOSAMINE NAG 0.3 mg
45 D-MALTOSE dMAL 0.3 mg
46 BACITRACIN RESISTANCE BACI 0.0006 mg
47 NOVOBIOCIN RESISTANCE NOVO 0.000075 mg
50 GROWTH IN 6.5% NaCl NC6.5 1.68 mg
52 D-MANNITOL dMAN 0.1875 mg
53 D-MANNOSE dMNE 0.3 mg
54 METHYL-B-D-GLUCOPYRANOSIDE MBdG 0.3 mg
56 PULLULAN PUL 0.3 mg
57 D-RAFFINOSE dRAF 0.3 mg
58 O/129 RESISTANCE ([Link].) O129R 0.0084 mg
59 SALICIN SAL 0.3 mg
60 SACCHAROSE/SUCROSE SAC 0.3 mg
62 D-TREHALOSE dTRE 0.3 mg
63 ARGININE DIHYDROLASE 2 ADH2s 0.27 mg
64 OPTOCHIN RESISTANCE OPTO 0.000399 mg

Note: Other well numbers between 1 and 64 not designated in this table are empty.
PRECAUTIONS
Note: For industry customers that need assistance on selecting the correct VITEK® 2 identification card, please refer to the
VITEK® 2 Compact Instrument User Manual chapter, "Guidance to Select a VITEK® 2 Identification Card."
• For In Vitro Diagnostic Use Only.
• For US Only: Caution: US Federal Law restricts this device to sale by or on the order of a licensed practitioner.
• For professional use only.
• Suspensions not within the appropriate zone on the VITEK® 2 DensiCHEK™ Plus or the VITEK® 2 DensiCHEK™ may
compromise card performance.
• Do not use the card after the expiration date shown on the package liner.
• Store the card unopened in the package liner. Do not use the card if the protective package liner is damaged or if no
desiccant is present.
• Allow the card to come to room temperature before opening the package liner.
• Do not use powdered gloves. Powder may interfere with the optics.
• Use of culture media other than the recommended types must be validated by the customer laboratory for acceptable
performance.
• A Gram stain should be performed to determine an organism’s Gram reaction and morphology prior to selecting the
identification card to inoculate.
• The card performs as intended only when used in conjunction with VITEK® 2 Systems, following the instructions
contained in these Instructions for Use.
• Do not use glass test tubes. Use clear plastic (polystyrene) tubes only. Variation exists among test tubes of standard
diameter. Carefully place the tube into the cassette. If resistance is encountered, discard and try another tube that does
not require pressure to insert.
• Prior to inoculation, inspect cards for tape tears or damage to the tape and discard any that are suspect. Check the
saline level in the tubes after the cassette has been processed to ensure proper filling of card.
• VITEK® 2 60 or VITEK® 2 XL: Eject improperly filled cards.
• VITEK® 2 Compact: Do not load improperly filled cards.
• Give special consideration to specimen source and patient drug or antimicrobic regimen.

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• Interpretation of test results requires the judgment and skill of a person knowledgeable in microbial identification testing.
Additional testing may be required. (See the Supplemental Tests section.)

Warning: All patient specimens, microbial cultures, and inoculated VITEK® 2 cards, along with associated materials,
are potentially infectious and should be treated with universal precautions.30,35
Warning: All hazardous waste must be disposed of by following your local inspecting agency's guidelines.
STORAGE CONDITIONS
Upon receipt, store VITEK® 2 GP cards unopened in their original package liner at 2°C to 8°C.
SPECIMEN PREPARATION
For specimen preparation information, see the Culture Requirements Table.

Culture Requirements Table

VITEK® 2 Card Media Age of Culture1 Incubation Inoculum Dilution for AST Age of
Conditions Density Suspension
Before Loading
Instrument
GP TSAB2,3 12 to 48 hours 35°C to 37°C 0.50 to 0.63 N/A4 ≤30 minutes
McFarland
CBA2,3 5% to 10% CO2
Standard
TSA2,3 or aerobic, non
CO2
BP
CHBA
CHOC
CHOC PVX
CNT
CPS ID
MRSA ID
MSA
SAID
TSAHB
TSAL
VRE
GP and AST TSAB 18 to 24 hours 35°C to 37°C 0.50 to 0.63 280 μL in 3.0 < 30 minutes
GP pair CBA 5% to 10% CO2 McFarland mL saline
Standard
CPS ID or aerobic, non-
CO2
GP and AST ST TSAB 18 to 24 hours 35°C to 37°C 0.50 to 0.63 280 μL in 3.0 < 30 minutes
pair CBA 5% to 10% CO2
McFarland mL saline
Standard

1Cultures with scant or poor growth may give unidentified or incorrect results even when the Age of Culture requirements are
met.
2These media were used in the identification product database development and will give optimal performance.
3OMA Official Methods of Analysis validated medium.
4N/A = not applicable
Culture Requirements Table — Media Abbreviations

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BP = Baird Parker
CBA = Columbia Blood Agar with 5% Sheep Blood
CHBA = Columbia Horse Blood Agar
CHOC = Chocolate Agar
CHOC PVX = Chocolate Polyvitex
CNT = Count-TACT®
CPS ID = chromID™ CPS (CPS ID agar)
MRSA ID = chromID™ (MRSA ID Agar)
MSA = Mannitol Salt Agar
SAID = chromID™ S. aureus (S. aureus ID Agar)
TSA = Trypticase Soy Agar
TSAB = Trypticase Soy Agar with 5% Sheep Blood
TSAHB = Trypticase Soy Agar with 5% Horse Blood
TSAL = TSA with Lecithin and P80
VRE = chromID™ VRE
TEST PROCEDURE
Materials
When used with VITEK® 2 instrumentation, the GP card is a complete system for routine identification testing of most
clinically significant Gram-positive organisms.
Required materials are:
• VITEK® 2 GP Card
• VITEK® 2 DensiCHEK™ Plus Kit or VITEK® 2 DensiCHEK™ Kit
• DensiCHEK™ Plus Standards Kit or DensiCHEK™ Standards Kit
• VITEK® 2 Cassette
• Sterile saline (aqueous 0.45% to 0.50% NaCl, pH 4.5 to 7.0)
• 12 mm x 75 mm clear plastic (polystyrene) disposable test tubes
• Sterile sticks or swabs
• Appropriate agar medium (see Culture Requirements table).

Optional accessories:
• Adjustable volume saline dispenser
• Loops
• Pre-dispensed saline test tubes (aqueous 0.45% to 0.50% NaCl, pH 4.5 to 7.0)
• Test tube caps
• Vortex

Procedure
Warning: Failure to follow instructions and recommendations provided in this section for performing laboratory
tasks may cause erroneous or delayed results.
For product-specific information, see the Culture Requirements table.
Note: Prepare the inoculum from a pure culture, according to good laboratory practices. In case of mixed cultures, a re-
isolation step is required. It is recommended that a purity check plate be done to ensure that a pure culture was used for
testing.
1. Do one of the following:
• Select isolated colonies from a primary plate if culture requirements are met.
• Subculture the organism to be tested to appropriate agar medium and incubate accordingly.

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2. Aseptically transfer 3.0 mL of sterile saline (aqueous 0.45% to 0.50% NaCl, pH 4.5 to 7.0) into a clear plastic
(polystyrene) test tube (12 mm x 75 mm).
3. Use a sterile stick or swab to transfer a sufficient number of morphologically similar colonies to the saline tube prepared in
step 2. Prepare a homogenous organism suspension with a density equivalent to a McFarland No. 0.50 to 0.63 using a
calibrated VITEK® 2 DensiCHEK™ Plus or VITEK® 2 DensiCHEK™.
Note: Age of suspension must not exceed 30 minutes before inoculating card.
4. Place the suspension tube and GP card in the cassette.
5. Refer to the appropriate Instrument User Manual for instructions on data entry and how to load the cassette into the
instrument.
6. Follow your local inspecting agency's guidelines for disposal of hazardous waste.
RESULTS
Identification Analytical Techniques
VITEK® 2 Systems identify an organism by using a methodology based on the characteristics of the data and knowledge
about the organism and reactions being analyzed. Sufficient data have been collected from known strains to estimate the
typical reactions of the claimed species to a set of discriminating biochemicals. If a unique identification pattern is not
recognized, a list of possible organisms is given, or the strain is determined to be outside the scope of the database.
The printed lab report contains suggestions for any supplemental tests necessary to complete the identification. If the tests
are not sufficient to complete the identification, then standard microbiology references and literature should be consulted.
Certain species may belong to slashline (mixed) taxa identification. This occurs when the biopattern is the same for the
taxa listed. Supplemental tests may be used to separate slashline taxa. The species in the GP Slashline Taxa table belong to
the GP slashline taxa.

GP Slashline Taxa

Slashline Name Species Belonging to the Slashline

Dermacoccus nishinomiyaensis/ Dermacoccus nishinomiyaensis
Kytococcus sedentarius Kytococcus sedentarius
Listeria ivanovii Listeria ivanovii ssp. ivanovii
Listeria ivanovii ssp. londoniensis
Staphylococcus capitis Staphylococcus capitis ssp. capitis
Staphylococcus capitis ssp. urealyticus
Streptococcus mitis/ Streptococcus mitis
Streptococcus oralis Streptococcus oralis
For 7.01 Software Users
Micrococcus luteus/lylae Micrococcus luteus
Micrococcus lylae

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Identification Card Qualifying Messages

ID Message Confidence Choices % Probability Comments

Level
Excellent 1 96 to 99 N/A
Very Good 1 93 to 95 N/A
Good 1 89 to 92 N/A
Acceptable 1 85 to 88 N/A
Low Discrimination 2 to 3 Sum of choices = 100; after Two to three taxa exhibit same
resolution to one choice, biopattern.
percent probability reflects
Separate by supplemental testing.
the number associated with
selected choice.
Inconclusive >3 N/A Either > 3 taxa exhibit same biopattern
or or or
Unidentified Organism 0 Very atypical biopattern. Does not
correspond to any taxon in the
database. Check Gram stain and
purity.

PERCENT PROBABILITY
As part of the identification process, the software compares the test set of reactions to the expected set of reactions of each
organism, or organism group, that can be identified by the product. A quantitative value, the percent probability, is calculated
and relates to how well the observed reactions compare to the typical reactions of each organism. A perfect match between
the test reaction pattern and the unique reaction pattern of a single organism, or organism group, would provide a percent
probability of 99. When a perfect match is not obtained, it is still possible for the reaction pattern to be sufficiently close to that
of an expected reaction pattern such that a clear decision can be provided about the organism identification. The range of
percent probabilities in the one-choice case is 85 to 99. Values closer to 99 indicate a closer match to the typical pattern for
the given organism.
When the reaction pattern is not sufficient to discriminate between two to three organisms, the percent probabilities reflect
this ambiguity. The reported probability values indicate, relatively, the order in which the reaction pattern best corresponds to
the listed possibilities. The order does not, however, suggest that the pattern match to one of the possible identifications is
clearly superior to another. The probability characteristic of an overall sum of 100 is retained through the calculation process.
After resolution to one choice, the probability characteristic of the single choice is retained.
ADDITIONAL INFORMATION ON LAB REPORT
Supplemental test — External (offline) test that allows the user to resolve a slashline or Low Discrimination identification.
Numbers in parentheses indicate percent positive reaction for the species/test listed.
Contraindicating test — Test result that is unusual for a reported taxon.

Notes Associated with Certain Taxa

Taxa Note
Enterococcus durans Possibility of Enterococcus villorum if veterinary.
Listeria monocytogenes Critical pathogen, check CAMP test and beta hemolysis.
The species identified may have significance to patient or
sample outcome and can be stopped for review.
Staphylococcus warneri Possibility of Staphylococcus pasteuri if yellow pigmented.
For 8.01 Software Users

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Taxa Note
Listeria innocua Possibility of Listeria monocytogenes.
Check for beta hemolysis. Listeria innocua strains are non-
hemolytic.

Notes Associated with an Improperly Filled Card or with a Negative Profile (Biopattern)
• For the case where the time between two readings is greater than 40 minutes: “CARD ERROR — Missing data.”
• For the case where there is a negative profile: “Organism with low reactivity biopattern — please check viability.”
• When a biopattern is calculated for an unknown organism that is completely negative or consists of both negative tests
and tests that fall within the uncertainty zone, the identification call will be “Non or low reactive biopattern.”

The following species could potentially trigger this note if a test was atypical or fell within the uncertainty zone:
• Alloiococcus otitis
• Dermacoccus nishinomiyaensis
• Gemella bergeri
• Kocuria rosea
• Kocuria varians
• Kytococcus sedentarius
• Leuconostoc mesenteroides ssp. cremoris
• Micrococcus lylae
• Staphylococcus auricularis
• Streptococcus pluranimalium

QUALITY CONTROL
Quality control organisms and their expected results are listed in the VITEK® 2 GP Quality Control Tables. Process these
according to the procedure for test isolates outlined in this document.
Certification Statement
This is to certify that bioMérieux complies with ISO 13485 and FDA Quality System Regulation (QSR) requirements for
design, development, and manufacture of microbial identification systems.
Frequency of Testing
Currently, it is recommended that you use your most stringent inspecting agency’s guidelines for frequency of identification
product testing.
Common practice is to perform QC upon receipt of shipment of the test kits. Reactions must follow Instructions for Use
results.
If the results do not meet the criteria, subculture for purity and repeat the test. If discrepant results are repeated, perform an
alternate identification method and contact bioMérieux.
Testing and Storage of QC Organisms
1. Rehydrate the organism according to the manufacturer's instructions.
2. Use Trypticase Soy with 5% sheep blood agar (TSAB) and incubate at 35°C to 37°C in 5% to 10% CO2 for approximately
18 to 24 hours.
3. Check for purity. Perform second subculture for testing.
Short-Term Storage Conditions
1. Subculture to a TSAB plate or slant.
2. Incubate for 24 hours at 35°C to 37°C in 5% to 10% CO2.
3. Refrigerate at 2°C to 8°C for up to two weeks.
4. Subculture once as described above and use for QC.
Long-Term Storage Conditions
1. Make a heavy suspension in Tryptic Soy Broth (TSB) with 15% glycerol.
2. Freeze at -70°C.
3. Subculture to TSAB twice before running QC.

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Note: Avoid repeated thawing and refreezing by either freezing in single-use aliquots or removing a small portion of frozen
organism preparation with a sterile applicator stick.
STREAMLINED QUALITY CONTROL
Note: Industrial Use Only laboratories should perform quality control following the Streamlined Quality Control section. No
additional testing is required for these users.
As there are no substrates that are consistently sensitive to degradation during shipping conditions, streamlined quality
control may be conducted by testing two strains: one that is mostly positive and the other, which is mostly negative for
reactions on GP. (See GP Quality Control tables for more details.)
COMPREHENSIVE QUALITY CONTROL
Customers who do not qualify for streamlined quality control testing are required to perform comprehensive quality control
testing, which entails demonstration of a positive and negative reaction for each substrate of an identification product.6
In order to qualify initially for streamlined quality control testing, the CLSI® M50-A standard requires that the user perform and
document either of the following:5
• Verification testing to show that performance is equivalent to the manufacturer's claims.
• Comprehensive quality control testing of at least three lots over at least three different seasons.

Refer to the complete CLSI® M50-A standard for information regarding continued qualification and further details of
requirements and responsibilities for both the user and the manufacturer related to streamlined quality control testing.
GP Quality Control Tables:
Enterococcus casseliflavus ATCC® 700327™ (for streamlined or comprehensive quality control)
Streptococcus salivarius ssp. thermophilus ATCC® 19258™ (for comprehensive quality control)
Kocuria kristinae ATCC® BAA-752™ (for comprehensive quality control)
Listeria monocytogenes ATCC® BAA-751™ (for comprehensive quality control)
Streptococcus pneumoniae ATCC® 49619™ (for comprehensive quality control)
Staphylococcus saprophyticus ATCC® BAA-750™ (for streamlined or comprehensive quality control)
Staphylococcus sciuri ATCC® 29061™ (for comprehensive quality control)
Streptococcus equi ssp. zooepidemicus ATCC® 43079™ (for comprehensive quality control)
Enterococcus saccharolyticus ATCC® 43076™ (for comprehensive quality control)
The GP card typically identifies the quality control organisms as one-choice or within a low discrimination or slashline
identification. However, strains are chosen for reaction performance over identification performance. Therefore, an
unidentified or misidentified result may occur when all expected quality control reactions are correct.

QC Organism: Enterococcus casseliflavus ATCC® 700327™ (for streamlined or comprehensive quality control)

AMY + CDEX - BGURr - URE - dMAL + PUL -

PIPLC - AspA v1 AGAL + POLYB + BACI + dRAF +
dXYL + BGAR + PyrA + dGAL + NOVO + O129R +
ADH1 + AMAN v BGUR - dRIB + NC6.5 + SAL +
BGAL + PHOS - AlaA v ILATk - dMAN + SAC +
AGLU v LeuA v TyrA + LAC + dMNE + dTRE +
APPA v ProA - dSOR v NAG + MBdG + ADH2s v
OPTO +

+ = 95% to 100% positive; v = 6% to 94% positive; – = 0% to 5% positive

1Reaction is mostly positive although occasional negative reaction may occur.

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QC Organism: Streptococcus salivarius ssp. thermophilus ATCC® 19258™ (for comprehensive quality control)

AMY v CDEX v BGURr v URE v dMAL - PUL v

PIPLC v AspA v AGAL v POLYB v BACI v dRAF v
dXYL v BGAR v PyrA v dGAL v NOVO v O129R v
ADH1 v AMAN v BGUR v dRIB v NC6.5 v SAL v
BGAL v PHOS v AlaA v ILATk v dMAN v SAC v
AGLU - LeuA v TyrA v LAC v dMNE v dTRE v
APPA v ProA v dSOR v NAG - MBdG v ADH2s v
OPTO v

+ = 95% to 100% positive; v = 6% to 94% positive; – = 0% to 5% positive

QC Organism: Kocuria kristinae ATCC® BAA-752™ (for comprehensive quality control)

AMY v CDEX v BGURr v URE v dMAL v PUL v

PIPLC v AspA – AGAL – POLYB v BACl – dRAF v
dXYL v BGAR v PyrA v dGAL v NOVO – O129R v
ADH1 v AMAN v BGUR v dRIB v NC6.5 v SAL v
BGAL – PHOS v AlaA v lLATk + dMAN v SAC v
AGLU + LeuA + TyrA v LAC – dMNE v dTRE v
APPA – ProA + dSOR v NAG v MBdG v ADH2s v
OPTO v

+ = 95% to 100% positive; v = 6% to 94% positive; – = 0% to 5% positive

QC Organism: Listeria monocytogenes ATCC® BAA-751™ (for comprehensive quality control)

AMY + CDEX + BGURr v URE v dMAL v PUL v

PIPLC + AspA v AGAL v POLYB + BACl v dRAF –
dXYL v BGAR – PyrA v dGAL – NOVO v O129R v
ADH1 – AMAN + BGUR v dRIB v NC6.5 + SAL v
BGAL – PHOS v AlaA v lLATk v dMAN – SAC –
AGLU + LeuA v TyrA v LAC v dMNE v dTRE v
APPA v ProA v dSOR v NAG + MBdG v ADH2s v
OPTO v

+ = 95% to 100% positive; v = 6% to 94% positive; – = 0% to 5% positive

QC Organism: Streptococcus pneumoniae ATCC® 49619™ (for comprehensive quality control)

AMY v CDEX v BGURr v URE v dMAL v PUL v

PIPLC v AspA v AGAL v POLYB v BACl – dRAF +
dXYL v BGAR v PyrA v dGAL v NOVO v O129R –
ADH1 v AMAN – BGUR v dRIB – NC6.5 – SAL +
BGAL v PHOS v AlaA + lLATk v dMAN v SAC v
AGLU v LeuA v TyrA v LAC v dMNE v dTRE v
APPA + ProA v dSOR v NAG v MBdG v ADH2s v
OPTO –

+ = 95% to 100% positive; v = 6% to 94% positive; – = 0% to 5% positive

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QC Organism: Staphylococcus saprophyticus ATCC® BAA-750™ (for streamlined or comprehensive quality control)

AMY - CDEX - BGURr - URE + dMAL + PUL -

PIPLC - AspA - AGAL - POLYB - BACI v dRAF -
dXYL - BGAR - PyrA v dGAL v NOVO + O129R v
ADH1 v AMAN - BGUR - dRIB v NC6.5 + SAL -
BGAL + PHOS v AlaA - ILATk v dMAN + SAC +
AGLU v LeuA - TyrA - LAC + dMNE v dTRE +
APPA v ProA - dSOR - NAG v MBdG - ADH2s -
OPTO +

+ = 95% to 100% positive; v = 6% to 94% positive; – = 0% to 5% positive

QC Organism: Staphylococcus sciuri ATCC® 29061™ (for comprehensive quality control)

AMY v CDEX v BGURr + URE – dMAL v PUL v

PIPLC v AspA v AGAL v POLYB – BACl v dRAF –
dXYL – BGAR v PyrA v dGAL v NOVO v O129R v
ADH1 + AMAN v BGUR + dRIB v NC6.5 v SAL v
BGAL v PHOS + AlaA – lLATk v dMAN v SAC v
AGLU v LeuA – TyrA – LAC – dMNE v dTRE +
APPA – ProA v dSOR v NAG v MBdG + ADH2s –
OPTO v

+ = 95% to 100% positive; v = 6% to 94% positive; – = 0% to 5% positive

QC Organism: Streptococcus equi ssp. zooepidemicus ATCC® 43079™ (for comprehensive quality control)

AMY v CDEX v BGURr v URE v dMAL v PUL v1

PIPLC v AspA v AGAL v POLYB v BACl v dRAF v
dXYL v BGAR v PyrA v dGAL + NOVO v O129R v
ADH1 v AMAN v BGUR v dRIB + NC6.5 v SAL v
BGAL v PHOS + AlaA v lLATk v dMAN v SAC v
AGLU v LeuA v TyrA v LAC v dMNE v dTRE –
APPA v ProA v dSOR v NAG v MBdG v ADH2s +
OPTO v

+ = 95% to 100% positive; v = 6% to 94% positive; – = 0% to 5% positive

1Reaction is mostly positive although occasional negative reaction may occur.

QC Organism: Enterococcus saccharolyticus ATCC® 43076™ (for comprehensive quality control)

AMY v CDEX + BGURr v URE v dMAL v PUL v

PIPLC v AspA v AGAL + POLYB v BACl v dRAF v
dXYL v BGAR v PyrA – dGAL v NOVO v O129R v
ADH1 v AMAN v BGUR v dRIB v NC6.5 v SAL v
BGAL v PHOS v AlaA v lLATk v dMAN + SAC v
AGLU v LeuA v TyrA v LAC v dMNE v dTRE v
APPA v ProA v dSOR + NAG v MBdG v ADH2s v
OPTO v

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+ = 95% to 100% positive; v = 6% to 94% positive; – = 0% to 5% positive

LIMITATIONS
The VITEK® 2 GP card cannot be used with a direct clinical specimen or sample or other sources containing mixed flora. Any
change or modification in the procedure may affect the results.
Newly described or rare species may not be included in the GP database. Selected species will be added as strains become
available.
Warning: Testing of unclaimed species may result in an unidentified result or a misidentification.
PERFORMANCE CHARACTERISTICS
In a multi-site clinical study*, the performance of the VITEK® 2 GP identification card was evaluated using 457 clinical and
stock isolates of both commonly and rarely observed species of gram-positive cocci. The reference identification was
determined with API® STAPH and API® 20 STREP identification kits. Overall, the VITEK® 2 GP correctly identified 96.1% of
the isolates, including 3.9% low discrimination with the correct species listed. Misidentifications occurred at 3.5% and no
identifications occurred at 0.4%.
*Data on file at bioMérieux, Inc.
ORGANISMS IDENTIFIED
• Abiotrophia defectiva
• Aerococcus urinae
• Aerococcus viridans
• Alloiococcus otitis
• Dermacoccus nishinomiyaensis/Kytococcus sedentarius
• Enterococcus avium
• Enterococcus casseliflavus
• Enterococcus cecorum
• Enterococcus columbae
• Enterococcus durans
• Enterococcus faecalis
• Enterococcus faecium
• Enterococcus gallinarum
• Enterococcus hirae
• Enterococcus raffinosus
• Enterococcus saccharolyticus
• Erysipelothrix rhusiopahiae
• Facklamia hominis
• Gardnerella vaginalis
• Gemella bergeri
• Gemella haemolysans
• Gemella morbillorum
• Gemella sanguinis
• Globicatella sanguinis
• Globicatella sulfidifaciens
• Granulicatella adiacens
• Granulicatella elegans
• Helcococcus kunzii
• Kocuria kristinae
• Kocuria rhizophila
• Kocuria rosea
• Kocuria varians
• Lactococcus garvieae
• Lactococcus lactis ssp. cremoris
• Lactococcus lactis ssp. lactis
• Lactococcus raffinolactis

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VITEK® 2 GP 043900- 02 - en - 2016-10

• Leuconostoc citreum
• Leuconostoc lactis
• Leuconostoc mesenteroides ssp. cremoris
• Leuconostoc mesenteroides ssp. dextranicum
• Leuconostoc mesenteroides ssp. mesenteroides
• Leuconostoc pseudomesenteroides
• Listeria grayi+
• Listeria innocua+
• Listeria ivanovii+
• Listeria monocytogenes+
• Listeria seeligeri+
• Listeria welshimeri+
• Micrococcus luteus
• Micrococcus lylae
• Pediococcus acidilactici
• Pediococcus pentosaceus
• Rothia dentocariosa
• Rothia mucilaginosa
• Staphylococcus arlettae
• Staphylococcus aureus *+
• Staphylococcus auricularis
• Staphylococcus capitis
• Staphylococcus caprae
• Staphylococcus carnosus ssp. carnosus
• Staphylococcus chromogenes
• Staphylococcus cohnii ssp. cohnii
• Staphylococcus cohnii ssp. urealyticus
• Staphylococcus epidermidis+
• Staphylococcus equorum
• Staphylococcus gallinarum
• Staphylococcus haemolyticus
• Staphylococcus hominis ssp. hominis
• Staphylococcus hominis ssp. novobiosepticus
• Staphylococcus hyicus+
• Staphylococcus intermedius+
• Staphylococcus kloosii
• Staphylococcus lentus
• Staphylococcus lugdunensis
• Staphylococcus pseudintermedius
• Staphylococcus saprophyticus
• Staphylococcus schleiferi
• Staphylococcus sciuri
• Staphylococcus simulans
• Staphylococcus vitulinus
• Staphylococcus warneri
• Staphylococcus xylosus
• Streptococcus agalactiae
• Streptococcus alactolyticus
• Streptococcus anginosus
• Streptococcus canis
• Streptococcus constellatus ssp. constellatus
• Streptococcus constellatus ssp. pharyngis

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VITEK® 2 GP 043900- 02 - en - 2016-10

• Streptococcus cristatus
• Streptococcus downei
• Streptococcus dysgalactiae ssp. dysgalactiae
• Streptococcus dysgalactiae ssp. equisimilis
• Streptococcus equi ssp. equi
• Streptococcus equi ssp. zooepidemicus
• Streptococcus equinus
• Streptococcus gallolyticus ssp. gallolyticus
• Streptococcus gallolyticus ssp. pasteurianus
• Streptococcus gordonii
• Streptococcus hyointestinalis
• Streptococcus infantarius ssp. coli (formerly known as Streptococcus lutetiensis)
• Streptococcus infantarius ssp. infantarius
• Streptococcus intermedius
• Streptococcus mitis/Streptococcus oralis
• Streptococcus mutans
• Streptococcus ovis
• Streptococcus parasanguinis
• Streptococcus pluranimalium
• Streptococcus pneumoniae
• Streptococcus porcinus
• Streptococcus pseudoporcinus
• Streptococcus pyogenes
• Streptococcus salivarius ssp. salivarius
• Streptococcus salivarius ssp. thermophilus
• Streptococcus sanguinis
• Streptococcus sobrinus
• Streptococcus suis I
• Streptococcus suis II
• Streptococcus thoraltensis
• Streptococcus uberis
• Streptococcus vestibularis
• Vagococcus fluvialis

For 8.01 Software Users

• Listeria fleischmannii
• Listeria rocourtiae
• Streptococcus iniae

*Staphylococcus aureus claim contains only the subspecies aureus.

+ OMA Official Methods of Analysis validated claim.
SUPPLEMENTAL TESTS

GP Supplemental Tests

Abbreviation Test Name Description Comments Reference

A-HEM ALPHA HEMOLYSIS Certain species produce N/A 21, 22, 23, 26, 27
incomplete hemolysis
resulting in a green
zone around colonies
on blood based media.

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VITEK® 2 GP 043900- 02 - en - 2016-10

Abbreviation Test Name Description Comments Reference

Acidification of: Acidification of carbon Some tests also appear 2, 3, 4, 8, 10, 14, 16, 17, 21, 22,
AMD/STARCH AMIDON/STARCH source observed with on the GP card but are 23, 26 , 27, 28, 31, 32, 33, 34, 36
pH indicators (e.g., recommended as
GLYCOGENac GLYCOGEN phenol red, bromcresol supplemental tests
IARABINOSE L-ARABINOSE acid. purple). since results of
conventional
INULIN INULIN macromethods may
MdG METHYL-A-DGLUCOPYRANOSIDE differ from rapid
commercial
MdM METHYL-A-DMANNOPYRANOSIDE
micromethods.
PULLULAN PULLULAN
SACCHAROSE SACCHAROSE (SUCROSE)
dGALACTOSE D-GALACTOSE
dMALTOSE D-MALTOSE
dMANNITOL D-MANNITOL
dMANNOSE D-MANNOSE
dMELEZIT D-MELEZITOSE
dMELIBIOSE D-MELIBIOSE
dRAFFINOSE D-RAFFINOSE
dRIBOSE D-RIBOSE
dSORBITOL D-SORBITOL
dTREHALOSE D-TREHALOSE
dXYLOSE D-XYLOSE
lRHAMNOSE L-RHAMNOSE
ANANE ALPHA-D-N-ACETYLNEURAMINIDASE Presence of respective Presence of enzyme is 7, 11, 21, 22, 23, 27, 28, 29, 31,
AIFUC ALPHA-L-FUCOSIDASE enzyme cleaves indicated by generation 34, 39
substrate generating of a colored or
BGLU BETA-GLUCOSIDASE detectable leaving fluorescent product, or a
BGURase BETA-GLUCURONIDASE group (e.g., p- noncolored product that
nitrophenol, methyl forms color upon
BNAG BETA-N-ACETYLGLUCOSAMINIDASE umbelliferone, beta- addition of a specific
BNAGA BETA-N-ACETYLGALACTOSAMINIDASE naphthylamide, beta- reagent.
naphthol, p-nitroaniline,
BdFUC BETA-D-FUCOSIDASE
7-amidomethyl-
PAL ALKALINE PHOSPHATASE coumarin).
Pyrro. Ary. Pyrrolidonyl ARYLAMIDASE
Adherence Adherence to agar Sticking of colonies to Characteristic of Rothia 27
the agar surface mucilaginosa
[Link] AEROBIC GROWTH Growth in air N/A 22
[Link]. ARGININE dihydrolase Hydrolysis of arginine N/A 2, 21, 22, 27, 36
releases an amine
resulting in alkalinization
of the medium observed
with a pH indicator (e.g.,
purple color formation in
the presence of
bromcresol purple).
B-HEM BETA HEMOLYSIS Certain species possess N/A 21, 22, 27, 37
hemolysins that give a
transparent zone
around colonies on
blood-based agars.
BILE SOL BILE SOLUBILITY Pneumococcal colonies Rapid test for 27
completely lyse and Streptococcus
disappear when pneumoniae
exposed to a 10%
solution of
deoxycholate.

bioMérieux - English - 14
VITEK® 2 GP 043900- 02 - en - 2016-10

Abbreviation Test Name Description Comments Reference

CAMP ([Link]) CAMP TEST (Staph. aureus) Synergistic hemolysis of N/A 27
Listeria monocytogenes
colonies by beta-toxin
producing colonies of
Staphylococcus aureus.
CAT CATALASE Colony placed on a drop Differentiation of 21, 22, 27, 38
of 3% hydrogen Micrococcaceae (+)
peroxide produces gas from Streptococcaceae
bubbles. The bacteria (–)
that contain cytochrome
enzyme are catalase
positive.
CLINDA.S Clindamycin susceptible Zone of inhibition Used to differentiate 15
around the clindamycin Lactococcus lactis and
disk > 20mm Lactococcus garvieae.
ESCULIN ESCULIN hydrolysis Hydrolysis of esculin N/A 3, 18, 21, 22, 24, 27
forms esculetin which
produces a black
pigment in the presence
of iron salts.
Gas prod. Gas production Production of CO2 from N/A 27
degradation
carbohydrate (e.g.,
glucose) metabolism.
HIP HIPPURATE hydrolysis Hydrolysis of sodium N/A 12, 21, 22, 26, 27
hippurate releases
glycine that produces a
blue colored product
after addition of
ninhydrin.
LAP LEUCINE AMINOPEPTIDASE The substrate leucine- N/A 19
beta-naphthylamide is
hydrolyzed by the
enzyme leucine
aminopeptidase and
released beta-
naphthylamide
combines with the
cinnamaldehyde
reagent to form a bright
pink to cherry red
pigment.
LitmusMILK Litmus Milk Medium Acid production in N/A 16
Litmus Milk
NaCl 6.5% GROWTH IN 6.5% NaCl Growth in 6.5% NaCl N/A 16, 19
broth
NO3 NITRATE REDUCTION Test for the ability to N/A 21, 22, 38
reduce nitrate to nitrite
or nitrogen gas.
NOVO_R NOVOBIOCIN_RESISTANCE Ability of certain species N/A 20, 21, 22, 27
to grow in the presence
OPTO_R OPTOCHIN_RESISTANCE
of specific antibacterial
VANCO_R VANCOMYCIN_RESISTANCE compounds
NaCl 7.5% GROWTH IN 7.5% NACL Ability of certain species N/A 22
to grow in the presence
of a high concentration
of NaCl
PI/OR/RED PINK/ORANGE/RED PIGMENT Ability of certain species Characteristic of 22, 27, 28
to produce pink, orange, Kocuria rosea
or red colonies on
nondifferential media
PVATE PYRUVATE Ability to use pyruvate N/A 28
as a sole carbon source

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VITEK® 2 GP 043900- 02 - en - 2016-10

Abbreviation Test Name Description Comments Reference

SATELLITE SATELLITE behavior Appearance of satellite Nutritionally deficient 9, 27
colonies of nutritionally Streptococcaceae
deficient require nutritional
Streptococcaceae factors supplied by
around colonies of metabolism of colonies
Staphylococcus of Staphylococcus
epidermidis. epidermidis.
[Link].A Strepto Serology A Agglutination tests for N/A 1, 13, 18, 21, 22, 24, 27, 28, 36
[Link].B Strepto Serology B Streptococcus groups
A,B,C,D, and G
[Link].C Strepto Serology C
[Link].D Strepto Serology D
[Link].G Strepto Serology G
UREASE Urease Hydrolysis of urea N/A 21, 22, 25, 27
releases ammonia,
resulting in alkalinization
of the medium observed
with a pH indicator (e.g.,
red color formation in
the presence of phenol
red).
VP VOGES PROSKAUER Ability of some species N/A 20, 21, 27, 34
to produce acetoin from
glucose fermentation.
YELLOW YELLOW PIGMENT Ability of certain species For example, used to 21, 22, 27, 28
to produce yellow differentiate E.
pigmented colonies on casseliflavus (+) from E.
nondifferential media. gallinarum (–).
Tests for 7.01 Software Users
BILE ESC BILE ESCULIN Bile-esculin positive N/A 18, 24
organisms are able to
grow in the presence of
40% bile and to
hydrolyze esculin.
CAROTENOID CAROTENOID PIGMENT Presence of red, pink, N/A 28
or orange pigment

REFERENCES
1. Balows A, Hausler Jr. WJ, Herrmann KL, Isenberg HD, Shadomy HJ. Manual of Clinical Microbiology 5th edition.
American Society of Microbiology, Washington, D.C.1991.
2. Barros RR, Carvalho GS, Peralta JM, Facklam RR, Teixeira LM. Phenotypic and Genotypic Characterization of
Pediococcus Strains Isolated from Human Clinical Sources. J. Clin. Microbiol. 2001. 39:1241- 1246.
3. Bille J, Catimel B, Bannerman E, Jacquet C, Yersin MN, Caniaux I, Monget D, Rocourt J. API Listeria, a New and
Promising One-Day System to Identify Listeria Isolates. Appl. Environ. Microbiol. 1992. 58:1857-1860.
4. Christensen JJ, Facklam RR. Granulicatella and Abiotrophia Species from Human Clinical Specimens. J. Clin. Microbiol.
2001. 39:3520-3523.
5. Clinical and Laboratory Standards Institute, M50-A, Quality Control for Commercial Microbial Identification Systems;
Approved Guideline, Vol. 28 No. 23.
6. Clinical Laboratory Improvement Amendments of 1988. 42 U.S.C 263a. PL 100-578. 1988.
7. Collins MD, Farrow JAE, Katic V, Kandler O. Taxonomic studies on streptococci of serological groups E, P, U and V:
description of Streptococcus porcinus sp. nov. Syst. Appl. Microbiol. 1984. 5:402-413.
8. Collins MD, Jones D, Farrow JAE, Kilpper-Bälz R, Schleifer KH. Enterococcus avium nom. rev., comb. nov.;
[Link] nom. rev., comb. nov.; E. durans nom. rev., comb. nov.; [Link] comb. nov.; and E. malodoratus
[Link]. Int. J. Syst. Bacteriol. 1984. 34:220-223.
9. Collins MD, Lawson PA. The genus Abiotrophia (Kawamura et al.) is not monophiletic: proposal of Granulicatella gen.
nov., Granulicatella adiacens [Link]., Granulicatella elegans comb. [Link] Granulicatella balaenopterae comb. nov.
Int. J. Syst. Evol. Microbiol. 2000. 50:365-369.
10. Collins MD, Hutson RA, Hoyles L, Falsen E, Nikolaitchouk N, Foster G. Streptococcus ovis sp. nov. isolated from sheep.
Int. J. Syst. Evol. Microbiol. 2001. 51:1147-1150.

bioMérieux - English - 16
VITEK® 2 GP 043900- 02 - en - 2016-10

11. Coykendall AL. Classification and Identification of the Viridans Streptococci. Clin. Microbiol. Rev. 1989. 2:315-328.
12. Duarte, R.S., R.R. Barros, R.R. Facklam and L.M. Teixeira. Phenotypic and Genotypic Characteristics of Steptococcus
porcinus J. [Link]. 2005 43(9): 4592-4601.
13. Devriese LA, Ceyssens K, Rodrigues UM, Collins MD. Enterococcus columbae, a species from pigeon intestines. FEMS
Microbiol Lett. 1990. 59(3):247-51.
14. Devriese LA, Kilpper-Bälz R, Schleifer KH. Streptococcus hyointestinalis [Link]. from the gut of swine. Int. J. Syst.
Bacteriol. 1988. 38:440-441.
15. Elliot JA, Facklam RR. Antimicrobial susceptibilities of Lactococcus lactis and Lactococcus garvieae and a proposed
method to discriminate between them. J. Clin. Microbiol. 1996. 34(5): 1296-1298.
16. Elliot JA, Facklam RR. Identification of Leuconostoc spp. by analysis of soluble whole-cell protein patterns. J. Clin.
Microbiol. 1993. 31(5):1030- 1033
17. Euzéby. Dictionnaire de Bactériologie Vétérinaire. Autres fichier : voir Accueil. Mise à jour : 02 février 2000. Principaux
caractéres permettant de différencier les espèces du genre Listeria. D’après :. BILLE (J.), ROCOURT (J).
18. Facklam RR. What Happened to the Streptococci: Overview of Taxonomic and Nomenclature Changes. Clin. Microbiol.
Rev. 2002.15:613-630.
19. Facklam R.R. and J.A. Elliott, Identification, Classification and Clinical Relevance of Catalast-Negative, Gram-Positive
Cocci, Excluding the Streptococci and Enterococci. Clin. Microbiol. Rev. 1995. 8(4): 479-495.
20. Farrow JAE, Facklam RR, Collins MD. Nucleic acid homologies of some vancomycin-resistant leuconostocs and
description of Leuconostoc citreum sp. nov. and Leuconostoc pseudomesenteroides sp. nov. Int. J. Syst. Bacteriol. 1989.
39:279-283.
21. Freney J, Renaud F, Hansen W, Bollet C. Précis de bactériologie clinique, ESKA, Paris, France. 2000.
22. Holt JG, Krieg NR, Sneath PHA, Staley JT, Williams ST, (editors) Bergey’s Manual of Determinative Bacteriology, 9th
edition. Williams and Wilkins, Baltimore, Maryland. 1994.
23. Kilpper-Bälz R, Schleifer KH. Streptococcus suis sp. nov., nom. rev. Int. J. Syst. Bacteriol. 1987. 37:160-162.
24. Koneman EW, Allen SD, Janda WM, Schreckenberger PC, Winn WC Jr. Color Atlas and Textbook of Diagnostic
Microbiology, 5th edition. Lippincott-Raven, Philadelphia, PA.1997.
25. Kovács G., J. Burghardt, S. Pradella, P. Schumann, E. Stackebrandt and K. Màrialigeti. Kocuria palusris sp. nov. and
Kocuria rhizophilia sp. nov., isolated from the rhizoplane of the narrow-leaved cattail (Typha angustifolia). Int. J. Syst.
Bacteriol., 1999, 49, 167-173.
26. Mahlen, S.D. and J.E. Clarridge III. Thumb Infection Caused by Streptococcus pseudoporcinus. [Link]. 2009.
47(9): 3041-3042.
27. Murray PR, Baron EJ, Pfaller MA, Tenover FC, Yolken RH, editors. Manual Of Clinical Microbiology, 7th edition. American
Society for Microbiology, Washington, D.C. 1999.
28. Murray PR, Baron EJ, Jorgensen JH, Pfaller MA, Yolken RH, editors. Manual Of Clinical Microbiology, Volume 1, 8th
edition. American Society for Microbiology, Washington, D.C. 2003.
29. Murray, P.R., E.J. Baron, M.L. Landry, J.H. Jorgensen and M.A. Pfaller. 2007. Manual of Clinical Microbiology, 9th edition.
American Society for Microbiology, Washington, D.C.
30. National Committee for Clinical Laboratory Standards, M29-A, Protection of Laboratory Workers from Instrument
Biohazards and Infectious Disease Transmitted by Blood, Body Fluids and Tissue — Approved Guideline, 1997.
31. Poyart C, Quesne G, Trieu-Cuot P. Taxonomic dissection of the Streptococcus bovis group by analysis of manganese-
dependent superoxide dismutase gene (sodA) sequences: reclassification of Streptococcus infantarius subsp. coli as
Streptococcus lutetiensis [Link]. and of Streptococcus bovis biotype II.2 as Streptococcus pasteurianus sp nov. Int. J.
Syst. Evol. Microbiol. 2002. 52:1247-1255.
32. Schlegel L, Grimont F, Collins MD, Regnault B, Grimont PAD, Bouvet A. Streptococcus infantarius sp. nov., Streptococcus
infantarius subsp infantarius subsp. nov. and Streptococcus infantarius subsp coli subsp. nov., isolated from humans and
food. Int. J. Syst. Evol. Microbiol. 2000. 50:1425-1434.
33. Schlegel, L., F. Grimont, E. Ageron, P. A. D. Grimont, and A. Bouvet. Reappraisal of the taxonomy of the Streptococcus
bovis/Streptococcus equinus complex and related species: description of Streptococcus gallolyticus subsp. gallolyticus
subsp. nov., S. gallolyticus subsp. macedonicus subsp. nov. and S. gallolyticus subsp. pasteurianus subsp. nov. Int. J.
Syst. Evol. Microbiol. 2003. 53:631-645.
34. Takashi, S., K. Kikuchi, Y. Tanaka, N. Takahashi, S. Kamata and K. Hiramatsu. Reclassification of Phenotypically
Identified Staphylococcus intermedius Strains. [Link]. 2007. 45(9): 2770-2778.
35. U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention,
National Institutes of Health, Office of Health and Safety, Biosafety in Microbiological and Biomedical Laboratories, 1988.
36. Versalovic J, Carroll KC, Funke G, Jorgensen JH, Landry ML, Warnock DW, editors. Manual Of Clinical Microbiology,
Volume 1, 10th edition. American Society for Microbiology, Washington, D.C. 2011.

bioMérieux - English - 17
VITEK® 2 GP 043900- 02 - en - 2016-10

37. Viera VV, Teixeira LM, Zahner V, Momen H, Facklam RR, Steigerwalt AG, Brenner DJ, Castro ACD. Genetic relationships
among the different phenotypes of Streptococcus dysgalactiae strains. Int. J. Syst. Bacteriol. 1998. 48:1231-1243.
38. Von Graevenitz, A. Rothia dentocariosa: taxonomy and differential diagnosis. [Link]. and Infection, 2004.
10:399-402.
39. Whiley RA, Hall LMC, Hardie JM, Beighton D. A study of small colony beta hemolytic, Lancefield group C streptococci
within the anginosus group: description of Streptococcus constellatus subsp. pharyngis [Link]., associated with the
human throat and pharyngitis. Int. J. Syst. Bacteriol. 1999. 49:1443-1449.
Use this Instructions for Use with VITEK® 2 Product No. 21342.
INDEX OF SYMBOLS

Symbol Meaning
Catalog number

In Vitro Diagnostic Medical Device

Legal Manufacturer

Temperature limitation

Use by date

Batch code

Consult Instructions for Use

Date of manufacture

Contains sufficient for <n> tests

Authorized representative in the

European Community
For US Only : Caution : US Federal
Law restricts this device to sale by
or on the order of a licensed
practitioner

Instructions for Use provided in the kit or downloadable from [Link]/techlib

LIMITED WARRANTY
bioMérieux warrants the performance of the product for its stated intended use provided that all procedures for usage,
storage and handling, shelf life (when applicable), and precautions are strictly followed as detailed in the instructions for use
(IFU).
Except as expressly set forth above, bioMérieux hereby disclaims all warranties, including any implied warranties of
merchantability and fitness for a particular purpose or use, and disclaims all liability, whether direct, indirect or consequential,
for any use of the reagent, software, instrument and disposables (the “System”) other than as set forth in the IFU.
WASTE DISPOSAL
All hazardous waste must be disposed of by following your local inspecting agency's guidelines.

bioMérieux - English - 18
VITEK® 2 GP 043900- 02 - en - 2016-10

REVISION HISTORY TABLE

Change type categories
N/A Not applicable (First publication)
Correction Correction of documentation anomalies
Technical change Addition, revision and/or removal of information related to the product
Administrative Implementation of non-technical changes noticeable to the user
Note : Minor typographical, grammar, and formatting changes are not included
in the revision history.

Release Date Part Number Change Type Change Summary

2016-10 043900-02 Technical change • Updated content to
reflect the 8.01 Product
Information Manual

2016-05 043900-01 Administrative • Formatting changes do

not affect the fit, form, or
function of the product

Technical change • New IFU derived from

product chapter in the
Product Information
Manual
• Updated Limited
Warranty section
• Updated with RX only
information

BIOMÉRIEUX, the BIOMÉRIEUX logo, VITEK, API, Count-TACT, chromID, DensiCHEK and bioLiaison are used, pending,
and/or registered trademarks belonging to bioMérieux, or one of its subsidiaries, or one of its companies.
This product may be protected by one or more patents, see: [Link]
The ATCC trademark and trade name and any and all ATCC catalog numbers are trademarks of the American Type Culture
Collection.
CLSI is a trademark belonging to Clinical Laboratory and Standards Institute, Inc.
Any other name or trademark is the property of its respective owner.
©BIOMÉRIEUX 2018

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Tel. 33 (0)4 78 87 20 00
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