Eu Ivdr
Eu Ivd Class B
On The Market
๐จ๐ฟ Czechia
RIA Testosterone
Devices (same UDI-DI)
1
Certificates
0
Countries
8
Notified Bodies
0
Basic Information
- Primary DI
- 15099590213626
- Basic UDI-DI Code
- 150995905IM10875L
- Reference
- IM1087
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class B
- Status
- On The Market
- Manufacturer
- IMMUNOTECH s.r.o.
Additional Description
RIA Testosterone is an in vitro diagnostic manual medical device intended to be used by healthcare professionals for the quantitative measurement of testosterone in human serum and plasma. Measurement of testosterone is intended to be used for the assessment of fertility status and sexual development. It is used in diagnosis and monitoring of androgen excess states in females. In males, it is used in diagnosis and monitoring of androgen insufficiency states and differential diagnosis of hypogonadism, hypopituitarism and hyperprolactinemia and as aid in diagnosis of precocious and delayed puberty in boys.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102050110 | TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE) |
Available In Countries
๐ง๐ช Belgium
๐จ๐ฟ Czechia
๐ซ๐ท France
๐ฑ๐ฎ Liechtenstein
๐ฑ๐บ Luxembourg
๐ฒ๐น Malta
๐ต๐น Portugal
๐ธ๐ฐ Slovakia
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