Color Control
Specifications 2. Before use, leave the control under room temperature
for 30 minutes.
REF Specifications 3. To use it, gently invert it several times to homogenize it.
4. During test with urine chemistry analyzer: put the
01.09.1F.01.04.04 Control (Red): 1×8 mL instrument at QC status. Pour the control into a dry and
clean test tube. Place the test tube at a test position in a
01.09.1F.01.04.05 Control (Green): 1×8 mL
compatible instrument for testing.
5. The test result shall be consistent with the indicated
01.09.1F.01.04.06 Control (Blue): 1×8 mL result. If not consistent, the user shall check the detection
system, such as the validity period of the control,
Control (Red, Green, Blue):
01.09.1F.01.04.03 performance and status of instrument, etc.
3×8 mL
Performance characteristics
Intended purpose Test value: the test result is the same as the indicated
This product is applicable to the QC test of urine value.
chemistry analyzer and urinalysis hybrid system. Uniformity: consistency of test results ≥90%.
Test principles Precautions
The QC of the test system is performed by measuring a 1. This product is only applicable to the QC test of color
control of with a known concentration, so as to ensure module of urine chemistry analyzer or urinalysis hybrid
the reliability of the results of from the instrument. system, and shall not be used for other purposes.
2. Avoid contact with the skin and eyes. If this product is
Main components splashed into the eyes, rinse with running warm water for
Control (Red): Carmie 0%-0.02% w/w. several minutes; seek medical attention immediately if
Control (Green): Tartrazine 0%-0.05% w/w, Brilliant Blue pain or swelling occurs. In case of contact with skin, rinse
0%-0.02% w/w. with soapy water, and completely rinse off the product
Control (Blue): Brilliant Blue 0%-0.02% w/w. with clean water.
3. Please use this product as required by the instructions.
The accuracy of the results cannot be guaranteed for
Materials provided
purposes other than the prescribed instructions and
Common intended purpose.
RED GREEN BLUE 3-color 4. Routine precautions for laboratory operations must be
component
followed when this product is used.
Color control 1bottle 1bottle 1bottle 3bottles
5. The control disposal and the containers that have been
Instructions
1 pc 1 pc 1 pc 1 pc in contact with the control shall follow the relevant waste
for use
regulations such as medical waste or industrial waste. All
Note: Products of different batches cannot be used waste shall be treated as a potential infection source.
together. 6. The control that was opened shall be sealed and stored
according to the specified method; do not use expired
Materials required (but not provided) products.
Urine analyzer, general laboratory equipment. 7. Please keep this product according to the storage
method, and avoid direct sunlight during operation.
Storage and stability
1. Unopened: the validity period is 18 months when Symbol interpretation
stored under 2-8°C and kept away from sunlight. The
product can't be stored under frozen conditions. Title and Title and
Symbol Symbol
2. Opened: the validity period is 30 days when stored Description Description
under 2-8°C and kept away from sunlight. The product In vitro
Date of
can't be stored under frozen conditions. diagnostic
manufacture
3. See packaging label for date of manufacture and expiry medical device
date. Batch code Use-by date
Applicable instruments
Consult
Zybio Urine chemistry analyzer (model: U1600, U1601, Temperature
instructions
U1602), Urinalysis hybrid system (model: U3600, U3601, limit
for use
U3602).
Keep away Catalogue
Assay procedure from sunlight number
Refer to the instructions on this product and the
instructions on compatible instruments. CE marking of
Manufacturer
1. The QC test shall be performed before the instrument conformity
restart or daily test, and controls 2 levels or more shall be
used for QC as much as possible.
Color Control
Authorized
Representative Unique
in the device
European identifier
Community
Control
References
1. Urinalysis and Collection, Transportation, and
Preservation of Urine Specimens; Approved
Guideline—Third Edition，from NCCLS Document GP16-A,
2009.
2. Cong Yulong, Ma Junlong, et al. Modern Urinalytical
Technology and Clinic Application, China Science and
Technology Press, 1998.
3. Cong Yulong, Ma Junlong, et al. Practical Urinalytical
Technology and Clinical Application, People's Health
Publishing House, first edition, September, 2013.
Zybio Inc.
No. 45, Shilin Avenue, Tiaodeng Town, Dadukou
District, 400082 Chongqing, PEOPLE'S REPUBLIC
OF CHINA
Tel: +86 (0)23 6895 9999
Fax: +86 (0)23 6869 9779
E-mail: info@[Link]
Web: [Link]
Lotus NL B.V.
Koningin Julianaplein 10, 1e Verd, 2595AA,
The Hague, Netherlands.
IFU Revision: 04 Release date: 2024-11-20