Eu Ivdr
Eu Ivd Class B
On The Market
๐จ๐ฟ Czechia
RIA Testosterone, direct
Devices (same UDI-DI)
1
Certificates
0
Countries
15
Notified Bodies
0
Basic Information
- Primary DI
- 15099590213657
- Basic UDI-DI Code
- 150995905IM111958
- Reference
- IM1119
- 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, direct 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
๐ฆ๐น Austria
๐ง๐ช Belgium
๐จ๐พ Cyprus
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ท France
๐ญ๐บ Hungary
๐ฎ๐น Italy
๐ฑ๐ฎ Liechtenstein
๐ฑ๐บ Luxembourg
๐ฒ๐น Malta
๐ต๐น Portugal
๐ธ๐ฐ Slovakia
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