← Back to catalogue
DELFIA Neonatal hTSH
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref A032-310
by Wallac Oy
Identity
- Trade Name
- DELFIA Neonatal hTSH EUDAMEDDELFIA Neonatal hTSH kit FDA UDI
- Generic Name
- Neonatal thyroid stimulating hormone (neonatal TSH) IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- DELFIA Neonatal hTSH EUDAMEDTime-resolved fluoroimmunoassay for the quantitative determination of human thyrotropin (thyroid stimulating hormone - hTSH) in dried blood. FDA UDI
- Model / Reference
- A032-310 EUDAMEDFDA UDI
- Description
- Time-resolved fluoroimmunoassay for the quantitative determination of human thyrotropin (thyroid stimulating hormone - hTSH) in dried blood. FDA UDI
Identifiers
- Catalog Number
- A032-310 FDA UDI
- Primary DI / UDI-DI
- 06438147140466 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06438147140466 EUDAMED
- FDA Product Code
- JLW FDA UDI
- EMDN Code
- W01020403 NEONATAL THYROID STIMULATING HORMONE EUDAMED
- GMDN Term
- Neonatal thyroid stimulating hormone (neonatal TSH) IVD, kit, fluorescent immunoassay FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1690 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
DELFIA Neonatal hTSH 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-06438147140466 | 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 023aece5-bf19-4039-8ef2-38235f52bd6c 61 fields · synced Jun 19, 2026
- FDA UDI 84092851-e3a6-4884-8bcb-388fe1b56455 35 fields · synced May 30, 2026