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Neonatal Biotinidase kit
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref 3018-001B
by Wallac Oy
Identity
- Trade Name
- Neonatal Biotinidase kit EUDAMEDFDA UDI
- Generic Name
- Biotinidase IVD, kit, enzyme fluorescence FDA UDI
- Device Name
- Neonatal Biotinidase kit EUDAMEDFor the semi-quantitative determination of biotinidase in dried blood. Note: Kit contains multiple packages. FDA UDI
- Model / Reference
- 3018-001B EUDAMEDFDA UDI
- Description
- For the semi-quantitative determination of biotinidase in dried blood. Note: Kit contains multiple packages. FDA UDI
Identifiers
- Catalog Number
- 3018-001B FDA UDI
- Primary DI / UDI-DI
- 06438147291359 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06438147291359 EUDAMED
- 510(k) Number
- K090123 FDA UDI
- FDA Product Code
- NAK FDA UDI
- EMDN Code
- W01010199 ENZYMES - OTHER EUDAMED
- GMDN Term
- Biotinidase IVD, kit, enzyme fluorescence FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1118 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Neonatal Biotinidase kit by Wallac Oy — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06438147291359 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- Manufacturer
- Wallac Oy
- EUDAMED SRN
- FI-MF-000022620
Sources (2)
- EUDAMED 31fc2311-99ac-488e-b10f-3363b67791d0 61 fields · synced Jul 13, 2026
- FDA UDI 7324118b-fbec-4ad2-aa4b-d6edc43a2557 36 fields · synced May 29, 2026