YY/T 1193-2011: Follicle stimulating hormone (FSH) quantitative immunoassay kit (chemiluminescent immunoassay)

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Scope

This standard specifies the product classification, requirements, test method, marks,
labels, instructions, packaging, transportation and storage etc. of the follicle stimulating
hormone (FSH) quantitative immunoassay kit (chemiluminescent immunoassay).
This standard is applicable to follicle stimulating hormone (FSH) kit [hereinafter referred
as “FSH kit”] of quantitative detection in human blood matrix or other body fluid
components, based on the principle of chemiluminescent immunoassay. It includes the
enzymatic and non-enzymatic chemiluminescent immunoassay detection kit in the
carriers of micro-plates, pipes, magnetic particles, micro-beads and plastic beads.
This standard does not apply to.
a) The calibrator and quality control product of follicle stimulating hormone intended for
separate sale;
b) Biochip that uses the principle of chemiluminescent immunoassay.
2  Normative references
The articles contained in the following documents have become part of this document
when they are quoted herein. For the dated documents so quoted, all the modifications
(Including all corrections) or revisions made thereafter shall be applicable to this
document.
GB/T 21415-2008 In vitro diagnostic medical devices - Measurement of quantities in
biological samples - Metrological traceability of values assigned to calibrators and
control materials

Basic Data

Standard ID	YY/T 1193-2011 (YY/T1193-2011)
Description (Translated English)	Follicle stimulating hormone (FSH) quantitative immunoassay kit (chemiluminescent immunoassay)
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C44
Classification of International Standard	11.100
Word Count Estimation	9,962
Date of Issue	2011-12-31
Date of Implementation	2013-06-01
Quoted Standard	GB/T 21415-2008
Regulation (derived from)	State Food and Drug Administration Notice 2011 No. 106; industry standard filing Notice 2013 No. 6 (No. 162 overall)
Issuing agency(ies)	State Food and Drug Administration
Summary	This standard specifies the follicle stimulating hormone (FSH) quantitative assay (box) (chemiluminescent immunoassay) classification, requirements, test methods, marking, labeling, instructions, packaging, transportation and storage. This standard applies to the principle of chemiluminescence immunoassay for the quantitative detection of human blood or other body fluids matrix components of follicle stimulating hormone (FSH) quantitative assay (box) [The following tube called "FSH Reagent (Box)"]. Including microplates, tubes, magnetic particles, beads and plastic beads, etc. as the carrier of enzymatic and non-enzymatic chemiluminescence immunoassay reagent (box). This standard does not apply to: a) intended for individual sales people follicle stimulating hormone calibrators and control materials follicle stimulating hormone, b) to chemiluminescent immunoassay for the principle of bio-chips.