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FSH Assay kit CLIA

Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
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Basic Information

Primary DI
06974521004110
Basic UDI-DI Code
B-06974521004110
Reference
SUPM064072
Device Types
Single use
Regulation
Eu Ivdd
Classification
Eu Ivd General
Status
On The Market

Additional Description

This kit is used for in vitro quantitative detection of follicle-stimulating hormone (FSH) in human serum and (or) plasma. Follicle-stimulating hormone (FSH) shows pulsatile secretion of gonadotropic cells of anterior pituitary gland and its level in the circulation is determined by negative feedback regulation of hypothalamus by steroid hormone. FSH is glycoprotein consisting of two subunits (α and β chains), whose molecular weight is about 32000 Dalton. For women, the menstrual cycle is formed through regulating gonadotropin by hypothalamus-hypophysis-ovarian axis. The following indications can be observed when luteinizing hormone is tested: Chromosomal aberration, polycystic ovaries (PCO), amenorrhea (pathogeny) and climacteric syndrome. For men, FSH can induce the development of spermatogonium and determination of its concentration is helpful for describing dysfunction of hypothalamus-hypophysis gonad axis.

CND Nomenclature Codes

Code Description
W0102050104 FOLLICLE STIMULATING HORMONE

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