Identity
- Trade Name
- AutoDELFIA Neonatal hTSH kit FDA UDI
- Generic Name
- Neonatal thyroid stimulating hormone (neonatal TSH) IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- Time-resolved fluoroimmunoassay for the quantitative determination of human thyrotropin (thyroid stimulating hormone - hTSH) in dried blood. FDA UDI
- Model / Reference
- B032-02C FDA UDI
- Description
- Time-resolved fluoroimmunoassay for the quantitative determination of human thyrotropin (thyroid stimulating hormone - hTSH) in dried blood. FDA UDI
Identifiers
- Catalog Number
- B032-02C FDA UDI
- Primary DI / UDI-DI
- 06438147179596 FDA UDI
- FDA Product Code
- JLW FDA UDI
- GMDN Term
- Neonatal thyroid stimulating hormone (neonatal TSH) IVD, kit, fluorescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1690 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
AutoDELFIA Neonatal hTSH kit by Wallac, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Wallac, Inc.
Sources (1)
- FDA UDI 2156f99f-9445-40d5-80aa-d23441a4bccf 36 fields · synced May 30, 2026