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YY/T 1742-2021: Adenosine deaminase testing kit
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1742-2021 | English | 149 |
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Adenosine deaminase testing kit
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YY/T 1742-2021
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Basic data | Standard ID | YY/T 1742-2021 (YY/T1742-2021) | | Description (Translated English) | Adenosine deaminase testing kit | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Word Count Estimation | 8,876 | | Issuing agency(ies) | State Drug Administration | YY/T 1742-2021: Adenosine deaminase testing kit---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Adenosine deaminase testing kit
ICS 11.100
C44
People's Republic of China Pharmaceutical Industry Standards
Adenosine Deaminase Assay Kit
Released on 2021-03-09
2022-10-01 implementation
Issued by the National Medical Products Administration
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. Publication of this document
The agency is not responsible for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is under the jurisdiction of the National Medical Clinical Laboratory and In Vitro Diagnostic System Standardization Technical Committee (SAC/TC136).
Drafting organizations of this standard. Shanghai Clinical Laboratory Center, Beijing Medical Device Inspection Institute, Shandong Brocade Bio-Industry Co., Ltd., Desai
System (Shanghai) Co., Ltd., Shanghai Kehua Biological Engineering Co., Ltd., Beijing Leadman Biochemical Co., Ltd., Intech Innovation (Xiamen)
Door) Technology Co., Ltd., Beijing Jiuqiang Biotechnology Co., Ltd.
The main drafters of this standard. Wang Hualiang, Euro Zhu, Yang Zhong, Xie Qinghua, Zou Yanfang, Xiao Lusheng, Ren Yikun, Lin Xiaorong, Chen Yang.
Adenosine Deaminase Assay Kit
1 Scope
This standard specifies the requirements, test methods, labels and instructions for use, packaging, transportation and storage of adenosine deaminase assay kits.
This standard applies to kits for the quantitative determination of adenosine deaminase in human serum and plasma samples by peroxidase method (hereinafter referred to as.
Kits), including reagents used on manual, semi-automatic and fully automatic biochemical analyzers.
2 Normative references
The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article
Pieces. For undated references, the latest version (including all amendments) applies to this document.
GB/T 29791.2 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 2.In vitro diagnostic reagents for professional use
3 requirements
3.1 Appearance
The appearance should meet the following requirements.
a) The components of the kit should be complete and complete, and there should be no leakage of liquid;
b) The package label document symbol should be clear.
3.2 Quantity
The net liquid content of the kit should not be less than the labeled value.
3.3 Reagent blank
3.3.1 Absorbance of reagent blank
When adding a blank sample to the reagent test, the absorbance of the reagent blank should not be large at the measurement wavelength (optical path 1cm) specified in the kit instructions
At 0.3.
3.3.2 Change rate of reagent blank absorbance
When adding a blank sample to the reagent test, the rate of change of the reagent blank absorbance (unit. ΔA/min) should not be greater than 0.02.
3.4 Analysis sensitivity
When measuring 25U/L samples, the absorbance change rate should not be less than 0.005.
3.5 Linear
The manufacturer shall specify the linear interval of the kit, at least covering the interval of [5,150] U/L, and meet the following requirements.
a) The linear correlation coefficient (r) should not be less than 0.990;
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