Eu Ivdr
Eu Ivd Class C
On The Market
๐จ๐ฟ Czechia
AFP screening IRMA KIT
Devices (same UDI-DI)
1
Certificates
0
Countries
12
Notified Bodies
0
Basic Information
- Primary DI
- 15099590203139
- Basic UDI-DI Code
- 150995905A37404SN
- Reference
- A37404
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class C
- Status
- On The Market
- Manufacturer
- IMMUNOTECH s.r.o.
Additional Description
AFP screening IRMA KIT is an in vitro diagnostic manual medical device intended to be used by healthcare professionals for the quantitative measurement of AFP in human serum and amniotic fluid. Measurement of AFP is intended to be used in risk assessment of neural tube defect and, in conjunction with other screening markers (hCG, uE3, โฆ), in risk assessment of Down syndrome (trisomy 21) in the 2nd trimester of pregnancy
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102050299 | PREGNANCY TESTING HORMONES - OTHER |
Available In Countries
๐ฆ๐น Austria
๐ง๐ช Belgium
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ท France
๐ญ๐บ Hungary
๐ฎ๐ช Ireland
๐ฎ๐น Italy
๐ฒ๐น Malta
๐ธ๐ฐ Slovakia
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