← Back to catalogue
Neonatal GALT
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref NG-4100
by Wallac Oy
Identity
- Trade Name
- Neonatal GALT EUDAMEDNeonatal GALT kit FDA UDI
- Generic Name
- Galactose-1-phosphate uridyl transferase IVD, kit, enzyme fluorescence FDA UDI
- Device Name
- Neonatal GALT EUDAMEDFor the quantitative determination of GALT (galactose-1-phosphate uridyl transferase) in dried blood. Note: Kit contains multiple packages. FDA UDI
- Model / Reference
- NG-4100 EUDAMEDFDA UDI
- Description
- For the quantitative determination of GALT (galactose-1-phosphate uridyl transferase) in dried blood. Note: Kit contains multiple packages. FDA UDI
Identifiers
- Catalog Number
- NG-4100 FDA UDI
- Primary DI / UDI-DI
- 06438147001279 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06438147001279 EUDAMED
- 510(k) Number
- K950803 FDA UDI
- FDA Product Code
- KQP FDA UDI
- EMDN Code
- W01010199 ENZYMES - OTHER EUDAMED
- GMDN Term
- Galactose-1-phosphate uridyl transferase IVD, kit, enzyme fluorescence FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1315 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
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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 GALT 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-06438147001279 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Wallac Oy
- EUDAMED SRN
- FI-MF-000022620
Sources (2)
- EUDAMED 6498e528-5d3c-4228-b5ed-e67784604ba9 61 fields · synced Jul 11, 2026
- FDA UDI 76b6ce5a-c5ef-4b3b-9d48-4c46055fb7d6 36 fields · synced May 30, 2026