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YY/T 1482-2016: Anti-herpes-simplex-virus IgG antibody detection reageant(kit)
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1482-2016 | English | 199 |
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Anti-herpes-simplex-virus IgG antibody detection reageant(kit)
| Valid |
YY/T 1482-2016
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PDF similar to YY/T 1482-2016
Basic data | Standard ID | YY/T 1482-2016 (YY/T1482-2016) | | Description (Translated English) | Anti-herpes-simplex-virus IgG antibody detection reageant(kit) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Word Count Estimation | 10,152 | | Date of Issue | 2016-07-29 | | Date of Implementation | 2017-06-01 | | Regulation (derived from) | State Food and Drug Administration Notice 2016 (No.129) | | Issuing agency(ies) | State Food and Drug Administration | YY/T 1482-2016: Anti-herpes-simplex-virus IgG 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 IgG antibody detection reageant (kit)
ICS 11.100
C44
People's Republic of China Pharmaceutical Industry Standard
Herpes simplex virus IgG antibody test 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 IgG antibody test reagent (box)
1 Scope
This standard specifies the technical requirements for herpes simplex virus IgG antibody detection reagent (box) [hereinafter referred to as "reagent"),
Law, labeling, labeling and instructions, packaging, transportation and storage.
This standard applies to the qualitative detection of human serum/plasma herpes simplex virus type 1 IgG antibody detection reagent (box), herpes simplex virus
2 type IgG antibody detection reagent (box), herpes simplex virus type 1 IgG antibody detection reagent (box), methodology for enzyme-linked immunoassay, chemical
Luminescence method, immunofluorescence method, immunoblotting method 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 request
3.1 Herpes simplex virus type 1 IgG antibody detection reagent (box)
3.1.1 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.
3.1.2 positive reference product compliance rate
A positive reference substance (dish) or a standardized positive reference was used for the detection of a herpes simplex virus type 1 IgG antibody assay reagent,
The results should meet the requirements.
3.1.3 Negative reference product compliance rate
A test was conducted with a herpes simplex virus type 1 IgG antibody assay reagent for a national negative reference or a standardized negative reference.
Should meet the requirements.
3.1.4 Minimum detection limit
With the herpes simplex virus type 1 IgG antibody detection reagent on the country's lowest detection limit reference material or the lowest reference limit
Line test, the results should meet the requirements.
3.1.5 Repeatability
Depending on the product characteristics, one of the following methods a) or b) can be verified.
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