Eu Ivdd
Eu Ivd Annex 2 List B
On The Market
🇫🇮 Finland
NeoMass AAAC 3.0
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 06438172402010
- Basic UDI-DI Code
- B-06438172402010
- Reference
- NeoMass AAAC 3.0
- 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 3.0 kit is for the quantitative measurement of amino acids, free carnitine, acylcarnitines, argininosuccinic acid, succinylacetone, lysophospholipid and nucleoside 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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