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Rayto Life and Analytical Sciences Co., Ltd.

Reagent Inspection and Analysis Report


Product Name Uric Acid Reagent (Uricase Method)

Specification R1: 50ml×4, R2: 25ml×2 / /


Semi-Auto or Auto Chemistry
Batch Applicable
Sample Size 3 boxes 20191031 Analyzer produced by Rayto Life
No. Instrument
and Analytical Sciences Co., Ltd.
Shelf Date of
Date of Inspection 2019.11.04 2020.10.30 2019.10.31
Life Production
Inspection Standard (Technical Requirements of
Inspection Item Inspection Results
Product)
R1 and R2 are both colorless, transparent liquid,
1 Appearance ☑Conformable □Inconformable
without cloudiness or undissolved materials.

The net content of liquid reagents should not be


2 Net content ☑Conformable □Inconformable
less than the indicated value.

Absorbance At 37℃, wavelength of 520nm and optic path


3 of reagent length of 10mm, the absorbance of reagent Result: 0.013A
blank blank should be ≤ 0.20A. ☑Conformable □Inconformable

4 Accuracy The relative deviation should not exceed ±10%. Result: 0.50%
☑Conformable □Inconformable
Result: Low-level: 0.92%
5 Repeatability Coefficient of Variation (CV) ≤4% High-level: 0.54%
☑Conformable □Inconformable
When testing the 0.65mmol/L calibrator or
Sensitivity for Result: 0.2217A
6 sample, at the optic path length of 10mm, the
analysis
absorbance difference (△A) should be ≥ 0.15A. ☑Conformable □Inconformable
Within the range of 0.02mmol/L ~ 1.50mmol/L
Linearity Result: 1.0000
7 (37℃), the correlation coefficient (r) should be ≥
range
0.990. ☑Conformable □Inconformable

Conclusion Conforming

Inspected by/ on Xiaomin Liu/2019.11.04 Checked by/ on Wanming Xian /2019.11.04

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