Eu Ivdd
Eu Ivd Annex 2 List B
On The Market
🇫🇮 Finland
NEOMASS AAAC PLUS
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 06438172403017
- Basic UDI-DI Code
- B-06438172403017
- Reference
- 7100110
- 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 CAH kit is intended for the determination of Androstenedione (ANDRO), Cortisol (CORT), 11-Deoxycortisol (11-DOC), 21-Deoxycortisol (21-DOC), 17-Hydroxyprogesterone (17-OHP) & 21-Hydroxyprogesterone (21-OHP) from whole blood dried on filter paper as a second tier test for detection of Congenital Adrenal Hyperplasia (CAH) in newborns.
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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