YY/T 1179-2010 English PDF

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YY/T 1179-2010: Carbohydrate antigen CA50 quantitative detection reagent (kit). Chemiluminescent immunoassay
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1179-2010	229	Add to Cart	3 days	Carbohydrate antigen CA50 quantitative detection reagent (kit). Chemiluminescent immunoassay	Valid

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Basic data

Standard ID: YY/T 1179-2010 (YY/T1179-2010)
Description (Translated English): Carbohydrate antigen CA50 quantitative detection reagent (kit). Chemiluminescent immunoassay
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C44
Classification of International Standard: 11.100
Word Count Estimation: 10,171
Date of Issue: 2010-12-27
Date of Implementation: 2012-06-01
Quoted Standard: GB/T 21415-2008
Regulation (derived from): State Food and Drug Administration Notice 2010 No. 97
Issuing agency(ies): State Food and Drug Administration
Summary: This standard specifies the quantitative side of the carbohydrate antigen CA50 given reagent (box) (chemiluminescent immunoassay) classification, requirements, test methods, marking, labeling, instructions, packaging, transportation and storage. This standard applies to chemiluminescence immunoassay for the quantitative determination of human principle carbohydrate antigen CA50 reagent (box). Including microplates, tubes, magnetic particles, beads and plastic beads, etc. as the carrier of enzymatic and non-enzymatic side chemiluminescent immunoassay reagent set (box). This standard does not apply to: a) intended to be used tumor markers sold separately tumor marker substance calibrators and control products, b) to chemiluminescent immunoassay for the principle of bio-chips.

YY/T 1179-2010: Carbohydrate antigen CA50 quantitative detection reagent (kit). Chemiluminescent immunoassay

---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.
Carbohydrate antigen CA50 quantitative detection reagent (kit) .Chemiluminescent immunoassay ICS 11.100 C44 People's Republic of China pharmaceutical industry standards Carbohydrate antigen CA50 quantitative assay reagent (kit) Chemiluminescence immunoassay CarbohydrateantigenCA50quantitativedetectionreagent (kit) - Issued on. 2010-12-27 2012-06-01 implementation State Food and Drug Administration issued

Foreword

This standard was drafted in accordance with GB/T 1.1-2009 given rules. Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents. This standard by the national medical clinical laboratory testing and in vitro diagnostic systems for Standardization Technical Committee (SAC/TC136) proposed. This standard by the national medical clinical laboratory testing and in vitro diagnostic systems for Standardization Technical Committee (SAC/TC136) centralized. This standard was drafted. Beijing Medical Device Testing, Beijing Chemclin Biotechnology Co., Ltd. The main drafters. Zhang Xinmei, Cheng Yinghao, Duhai Ou. Carbohydrate antigen CA50 quantitative assay reagent (kit) Chemiluminescence immunoassay

1 Scope

This standard specifies the quantitative determination of carbohydrate antigen CA50 reagent (box) (chemiluminescent immunoassay) classification, requirements, test methods, Logos, labels, brochures, packaging, transportation and storage. This standard applies to chemiluminescent immunoassay for the quantitative determination of the principles of human carbohydrate antigen CA50 reagent (box) [hereinafter referred to as "CA50 reagent (kit)"]. Including microplates, tubes, magnetic particles, beads and plastic beads as the carrier of enzymatic and non-enzymatic chemiluminescence immunoassay Analysis assay reagent (kit). This standard does not apply to. a) to be used for sales of individual tumor markers and tumor marker substance calibrator control products; b) by CLIA for the principle of biochips.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document. GB/T 21415-2008 vitro diagnostic medical devices - Measurement of quantities in biological samples calibration and control materials assigned metrology Traceability Category 3 CA50 reagent (box) in accordance with the principle of chemiluminescence can be divided into enzymatic and non-enzymatic chemiluminescence immunoassay reagent (kit); solid basis In phase carrier it can be divided into microplates, tubes, magnetic particles, beads and plastic beads as the carrier chemiluminescence immunoassay reagent (kit); according to the operating As the process can be divided into different manual method and automated method of automatic operation.

4 Requirements

4.1 Appearance The skin should meet the following requirements. a) reagent (box) of each component should be complete, complete, no liquid leakage; b) packaging labels should be clear and easy to identify. 4.2 Traceability Manufacturers should provide with CA50 calibrator sources, the assignment process and measured according to GB/T 21415-2008 and the relevant provisions Uncertainty and so on. 4.3 Accuracy Accuracy should meet one of the requirements are as follows. ......

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