0123 0123
Physical Module Control Physical Module Control
Initial Version and swelling occurs. In case of contact with skin, rinse with soapy Technical assistance
01, 2024-01-15
Issue Date water, and completely rinse off the product with clean water. For customer support, contact your local technical support
Current Version and Please use this product as required by the instructions. The provider or distributor.
03, 2024-11-20
Revision Date accuracy of the results cannot be guaranteed for purposes
Document ID 3-02-70-01-1207-00-01 other than the prescribed instructions and intended purpose.
Routine precautions for laboratory operations must be References
Model / followed when this product is used. 1. China Committee for Clinical Laboratory Standards,
Language English The product contains hazardous chemical substance. Wear Urinalysis and Collection, Transportation and Preservation of
protective gloves/ protective clothing/eye protection/face Urine Specimens; Approved Guideline-Translated from
Urine Chemistry Analyzer (Models: protection in the lab, so as to protect yourself when using. NCCLs Document GP16-A, 1995
U1600, U1601, U1602) 2. Cong Yulong, Ma Junlong, et al. Modern Urinalysis
Disposal into drain systems must be in compliance with
manufactured by Zybio.
prevailing regulatory requirements. Techniques and Clinical Application, China Science &
Urine Sediment Analyzer (Models:
The product contains proClin300. Wear protective gloves/ Technology Press, 1998
U2600, U2601, U2602, U2610,
Systems protective clothing/eye protection/face protection in the lab. 3. Cong Yulong, Ma Junlong et al. Practical Urinalysis
U2611, U2612) manufactured by
Zybio. Disposal into drain systems must be in compliance with Techniques and Clinical Application, People ’ s Medical
Urinalysis Hybrid System (Models: prevailing regulatory requirements. Publishing House, First Edition, September 2013
U3600, U3601, U3602) This product shall be stored as instructed, and kept away
manufactured by Zybio. from direct sunlight during operation. Symbol Interpretation
Instructions for use must be carefully followed, reliability of No freezing during transportation.
assay results cannot be guaranteed if there are any deviations. For professional use only. Title and Title and
Symbol Symbol
For in vitro diagnostic use only. Description Description
Storage & Stability In vitro
diagnostic Batch code
Intended purpose Unopened: the validity period is 12 months when stored
medical device
This product is used for conductivity, specific gravity, turbidity under 2-8°C and kept away from sunlight. The product can't
Consult
and color quality control of PHYC module on Zybio urinalysis be stored under frozen conditions.
instructions for Use-by date
systems. Opened: the validity period is 30 days when stored under 2-8 use
°C and kept away from sunlight. The product can't be stored CE mark with
under frozen conditions. identification
Assay Principles See packaging label for date of manufacture and expiry date. 0123 Manufacturer
number of
The QC of the test system is performed by measuring a control notified body
with a known concentration, to ensure the reliability of results Authorized
Assay Procedure
from the instrument. Representative
Refer to the instructions on this product and the instructions on Temperature
in the
compatible instruments. limit
Reagents Specification European
Controls 3 levels shall be used for QC as much as possible. Community
Before use, leave the control under room temperature for 30 Catalogue Date of
REF Specification
minutes. number manufacture
1200201 3 levels × 1 vial × 8mL Gently invert it several times to homogenize it. Unique
During test: put the instrument at QC status, pour the control Keep away device
into a dry and clean test tube, place the test tube at a test from sunlight identifier
Reagents Components position in a compatible instrument for testing.
Control Warning
The test result shall be consistent with the indicated result. If
Level Components
not consistent, the user shall check the detection system,
Potassium chloride 0.07-0.09%w/w, brilliant such as the validity period of the control, performance and Zybio Inc.
Level 1 blue 0.0001-0.002%w/w, citron yellow 0.001- status of instrument, etc. No. 45, Shilin Avenue, Tiaodeng Town, Dadukou
0.02% w/w. ProClin 300 0.01%-0.1% w/w. District, 400082 Chongqing, PEOPLE'S REPUBLIC
OF CHINA
Potassium chloride 1-1.5% w/w, urea 2.75- Limitations of test methods
Web: [Link]
Level 2 3.25% w/w, Formazin 90-110 NTU, brilliant This product is used in conjunction with applicable analyzers. E-mail: info@[Link]
blue 0.001-0.01% w/w The acceptable range of quality control products is limited to Tel: +86 (0)23 6895 9999
Potassium chloride 3.25-3.75% w/w, urea the models declared in the applicable models. Therefore, only Fax: +86 (0)23 6869 9779
Level 3 3.25-3.75% w/w, Formazin 630-770 NTU, the data established by the same method can be compared.
carmine 0.001-0.02% w/w QbD RepS BV
Groenenborgerlaan 16, 2610 Wilrijk, Belgium
This product is of batch specificity, and reagents with different Performance Characteristics
batch No. cannot be mixed. Test values: Test results shall be within the indicated range.
Homogeneity:
Warnings and Precautions Items Level 1 Level 2 Level 3
This product is only applicable to the QC of conductivity, Conductivity / CV between-bottle≤5%
specific gravity, turbidity and color module of Zybio urinalysis Specific Gravity / CV between-bottle≤5%
system. Please do not use it for other purposes. Turbidity The consistency of test results≥90%
Avoid contact with the skin and eyes. If this product is Color The consistency of test results≥90%
splashed into eyes, flush with running warm water for several
minutes; seek medical treatment immediately if pain or
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