Eu Ivdr
Eu Ivd Class B
On The Market
🇨🇳 China
Testosterone CLIA Microparticles
Devices (same UDI-DI)
1
Certificates
0
Countries
3
Notified Bodies
0
Basic Information
- Primary DI
- 06970150908676
- Basic UDI-DI Code
- 697015090000029H8
- Reference
- CMF0402
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class B
- Status
- On The Market
- Manufacturer
- Autobio Diagnostics Co., Ltd.
Additional Description
The Testosterone CLIA Microparticles assay is based on the fully automated chemiluminescent microparticle immunoassay (CLIA Microparticles) system for the quantitative determination of Testosterone concentration in human serum. Testosterone is used as an aid in the diagnosis of precocious puberty and hypogonadism in men, and hypertrichosis and menstrual abnormalities in women.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102050110 | TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE) |
Available In Countries
🇮🇹 Italy
🇷🇴 Romania
🇹🇷 Türkiye
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