Devices (same UDI-DI)
1
Certificates
0
Countries
1
Notified Bodies
0
Basic Information
- Primary DI
- 15099590787486
- Basic UDI-DI Code
- 150995905D00324RC
- Reference
- D00324
- Device Types
-
New device
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class B
- Status
- On The Market
- Manufacturer
- IMMUNOTECH s.r.o.
Additional Description
AMH Gen II ELISA is an in vitro diagnostic manual medical device intended to be used by healthcare professionals for the quantitative measurement of Anti-Müllerian hormone (AMH) in human serum and plasma. Measurement of AMH is intended to be used for the assessment of fertility status and sexual development. In females, it is used to assess ovarian and menopausal status, including ovarian reserve, and as an aid in diagnosis of PCOS. It is used as an aid in differential diagnosis of intersex conditions in infants.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102050215 | ANTI-MÛLLERIAN HORMONE |
Available In Countries
🇨🇿 Czechia
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