Path: Home > YY/T > Page2 > YY/T 1237-2014

Price & Delivery

US$169.00 · In stock · Download in 9 seconds
YY/T 1237-2014: Diagnostic kit for IgG antibody to toxophasma (EL1SA)
Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure
Status: Valid

Std ID	Version	USD	Buy	Deliver [PDF] in	Title (Description)
YY/T 1237-2014	English	169	Add to Cart	3 days [Need to translate]	Diagnostic kit for IgG antibody to toxophasma (EL1SA)

YY/T 1237-2014: Diagnostic kit for IgG antibody to toxophasma (EL1SA)

---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.
Diagnostic kit for IgG antibody to toxophasma (EL1SA) ICS 11.100 C44 People's Republic of China pharmaceutical industry standards Toxoplasma IgG antibody detection reagent (box) (ELISA) DiagnostickitforIgGantibodytotoxophasma (ELISA) Issued on. 2014-06-17 2015-07-01 implementation China Food and Drug Administration released

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 was proposed by the China Food and Drug Administration. 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. Chinese Academy of Food and Drug test. The main drafters. Zhang Jin, Xin Xiaofang, SOCIALIST Bai Dongting thin Shuying, the Premiership Yang, Zhang Ying, Tang Hanwen, Ren Jun. Toxoplasma IgG antibody detection reagent (box) (ELISA)

1 Scope

This standard specifies the Toxoplasma IgG antibody detection reagent (box) (enzyme-linked immunosorbent assay) requirements, test methods, marking, labeling, the use of said Specification, packaging, transportation and storage. This standard applies to legal ELISA detection in human serum, plasma Toxoplasma IgG antibody detection reagent (box).

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 191 Packaging - Pictorial signs

3 Requirements

3.1 Appearance The kit should look neat, text and clearly labeled, the liquid component should be clarified. 3.2 Reference product meets the negative rate For examination by national reference or with standardized reference sera should meet the requirements. 3.3 Reference product meets the positive rate For examination by national reference or with standardized reference sera should meet the requirements. 3.4 The minimum detection limit For examination by national reference or with standardized reference sera should be no higher than 5IU/mL. 3.5 Precision For examination by national reference or with standardized reference sera, CV should be no higher than 15% (n = 10). 3.6 Stability 37 ℃ for n days [n = product remaining Term (months) ÷ 1.6 (month/day)], the test results shall comply with the requirements of 3.2 to 3.5. Test Method 4 4.1 Appearance With normal or corrected vision was observed, the result should meet the requirements of 3.1. ...