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YY/T 1193-2011 English PDF (YYT1193-2011)

YY/T 1193-2011 English PDF (YYT1193-2011)

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

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