Eu Ivdd
Eu Ivd Annex 2 List B
On The Market
🇫🇮 Finland
Neonatal Phenylalanine
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
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Basic Information
- Primary DI
- 06438172085015
- Basic UDI-DI Code
- B-06438172085015
- Reference
- 6199896
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List B
- Status
- On The Market
- Manufacturer
- Labsystems Diagnostics Oy
Additional Description
The kit is designed for the quantitative in vitro determination of phenylalanine concentration in blood specimens dried on filter paper intended for newborn screening for phenylketonuria (PKU).
CND Nomenclature Codes
| Code | Description |
|---|---|
| W01010236 | PHENYLKETONURIA |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | C-02-1172-794-22 | Eurofins Electric & Electronics Finland Oy | Expired |
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