Path: Home > YY/T > Page2 > YY/T 1483-2016

Price & Delivery

US$139.00 · In stock · Download in 9 seconds
YY/T 1483-2016: Anti-herpes-simplex-virus IgM antibody detection reageant(kit)
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 1483-2016	English	139	Add to Cart	3 days [Need to translate]	Anti-herpes-simplex-virus IgM antibody detection reageant(kit)

YY/T 1483-2016: Anti-herpes-simplex-virus IgM antibody detection reageant(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.
Anti-herpes-simplex-virus IgM antibody detection reageant (kit) ICS 11.100 C44 People's Republic of China Pharmaceutical Industry Standard Herpes simplex virus IgM antibody detection reagent (box) 2016-07-29 released 2017-06-01 implementation State Food and Drug Administration issued

Foreword

This standard is 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. The release of this document The Agency does not assume responsibility for identifying these patents. This standard is proposed by the State Food and Drug Administration. This standard by the National Medical Laboratory Laboratory and in vitro diagnostic system Standardization Technical Committee (SAC/TC136) centralized. The drafting unit of this standard. China Food and Drug Administration Research Institute. The main drafters of this standard. Huang Jie, Qu Shoufang, Gao Shangxian Herpes simplex virus IgM antibody detection reagent (box)

1 Scope

This standard specifies the technical requirements for herpes simplex virus IgM antibody detection reagent (box) [hereinafter referred to as "reagent (box)"], the test method Law, labeling, labeling and instructions, packaging, transportation and storage. This standard is suitable for qualitative detection of human serum/plasma herpes simplex virus type 1 IgM antibody detection reagent (box), methodology Enzyme immunoassay, chemiluminescence, immunofluorescence, immunoblotting, and the like.

2 normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article Pieces. For undated references, the latest edition (including all modifications) applies to this document. GB/T 191 Packaging and storage icon (ISO 780) YY/T 0466.1 Symbols for medical devices for labeling, labeling and providing information on medical devices - Part 1. General requirements (ISO 15223-1) 3 herpes simplex virus type 1 IgM antibody test reagent (box) requirements 3.1 appearance Appearance should meet the following requirements. a) kit components should be complete, complete, liquid without leakage; b) Chinese packaging labels should be clear, no wear. 3.2 positive reference product compliance rate With the herpes simplex virus type 1 IgM antibody detection reagents on the national positive reference material or standardized positive reference material for testing, The results should meet the requirements. 3.3 Negative reference product compliance rate The use of herpes simplex virus type 1 IgM antibody detection reagent for the detection of national negative reference material or standardized negative reference material, The results should meet the requirements. 3.4 Minimum detection limit Use the herpes simplex virus type 1 IgM antibody assay reagent to the national minimum detection limit reference or the standard minimum detection limit Product for testing, the results should meet the requirements. 3.5 Repeatability Depending on the product characteristics, one of the following methods a) or b) can be verified. a) Use the herpes simplex virus type 1 IgM antibody assay reagent to the national repeat reference or the standard repeatable reference The coefficient of variation (CV,%) should not exceed 15.0%. ...