Eu Ivdd
Eu Ivd Annex 2 List B
On The Market
🇫🇮 Finland
MULTIPLE SUBSTRATES ONLY - CLIN. CHEM LAB R.
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 06438172400016
- Basic UDI-DI Code
- B-06438172400016
- Reference
- 7100100
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List B
- Status
- On The Market
- Manufacturer
- Labsystems Diagnostics Oy
Additional Description
This NeoMass AAAC kit is for the quantitative measurement of amino acids, free carnitine and acylcarnitines in blood samples dried on filter paper as a primary test for screening of newborns for inborn errors of metabolism.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W01010402 | MULTIPLE SUBSTRATES ONLY - CLIN. CHEM LAB R. |
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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