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YY/T 1583-2018: Folate testing kit (chemiluminescent immunoassay)
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Std ID	Version	USD	Buy	Deliver [PDF] in	Title (Description)
YY/T 1583-2018	English	139	Add to Cart	3 days [Need to translate]	Folate testing kit (chemiluminescent immunoassay)

YY/T 1583-2018: Folate testing 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.
Folate testing kit(chemiluminescent immunoassay) ICS 11.100 C44 People's Republic of China Pharmaceutical Industry Standard Folic acid assay kit (chemiluminescence immunoassay) Published on.2018-02-24 2019-03-01 implementation State Food and Drug Administration issued

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 organization is not responsible for identifying these patents. This standard was proposed by the State Food and Drug Administration. This standard is under the jurisdiction of the National Medical Clinical Laboratory and the In vitro Diagnostic System Standardization Technical Committee (SAC/TC136). This standard was drafted. Beijing Medical Device Inspection Institute, Abbott Trade (Shanghai) Co., Ltd., Shenzhen New Industry Biomedical Engineering Limited. The main drafters of this standard. Zou Yingying, Yan Juan, Wang Xuefeng, Yuan Jinyun. Folic acid assay kit (chemiluminescence immunoassay)

1 Scope

This standard specifies the requirements, test methods and standards for the folic acid determination kit (chemiluminescence immunoassay) (hereinafter referred to as "kit"). Identification, labeling and instructions for use, packaging, transportation and storage. This standard applies to the kit for quantitative determination of folic acid in human serum by chemiluminescence immunoassay, including microplates, An enzymatic and non-enzymatic chemiluminescence immunoassay kit for the determination of tubes, magnetic particles, microbeads, and plastic beads. This standard does not apply to. a) determination of folic acid content in human erythrocytes; b) Folic acid calibrators and folic acid controls intended for sale separately; c) Biochips based on chemiluminescence immunoassay.

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article. Pieces. For undated references, the latest edition (including all amendments) applies to this document. GB/T 191 packaging storage and transportation icon GB/T 21415 in vitro diagnostic medical device biological sample medium quantity measurement calibrator and control substance evaluation Source GB/T 29791.2 Information provided by in vitro diagnostic medical device manufacturers (labeling) Part 2. Professional in vitro diagnostic reagents

3 requirements

3.1 Appearance The components of the kit should be complete and complete, and the liquid should be free of leakage. 3.2 Traceability The manufacturer shall provide the source, valuation process and measurement uncertainty of the folic acid calibrator used according to GB/T 21415 and relevant regulations. Degree and other content. 3.3 Accuracy You can use one of the following methods to verify (if applicable, the method of relative bias is preferred). a) Relative Deviation. Determined using a Certified Reference Material (CRM) that can be used to evaluate conventional methods. The deviation should be within ±15%; b) Recovery test. The recovery rate should be in the range of [85%, 115%]. 3.4 Checkout limit The detection limit should be no more than 1.0 ng/mL. ...