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Diagnostic Kit for TES (Testosterone) (Time-resolved Fluorescence Immunochromatographic Assay)

Devices (same UDI-DI)
1
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Countries
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Basic Information

Primary DI
06974521003335
Basic UDI-DI Code
B-06974521003335
Reference
SUPF047025
Device Types
Single use
Regulation
Eu Ivdd
Classification
Eu Ivd General
Status
On The Market

Additional Description

The Diagnostic Kit for TES (Testosterone) (Time-resolved Fluorescence Immunochromatographic Assay) is suitable for in vitro quantitative detection of the concentration of TESTO in human serum or plasma samples. TESTO (17β-hydroxyandrosterone-4-alkene-3-ketone) is an anabolic steroid, mainly synthesized by testicular stromal cells in the ovaries and adrenal glands of male and female. It is synthesized from cholesterol, androstene glycol, dehydroepiandrosterone (DHEA), progesterone and pregnenolone as intermediate substrates. Male TESTO levels increase by 10 to 20 times during puberty, which promotes the physiological changes associated with male puberty. It has a powerful and extensive impact on emotional health, sexual function, muscle mass and strength, energy, cardiovascular health, bone integrity and cognitive abilities throughout a lifetime. In the blood, only 1% to 15% of TESTO is unbound or biologically active, and the remaining testosterone is bound to serum proteins.

CND Nomenclature Codes

Code Description
W0102050110 TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)

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