Identity
- Trade Name
- GSP Neonatal Thyroxine (T4) kit FDA UDI
- Generic Name
- Neonatal thyroxine (neonatal T4) IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- For the quantitative determination of thyroxine (T4) in dried blood. FDA UDI
- Model / Reference
- 3302-001U FDA UDI
- Description
- For the quantitative determination of thyroxine (T4) in dried blood. FDA UDI
Identifiers
- Catalog Number
- 3302-001U FDA UDI
- Primary DI / UDI-DI
- 06438147312139 FDA UDI
- 510(k) Number
- K103484 FDA UDI
- FDA Product Code
- KLI FDA UDI
- GMDN Term
- Neonatal thyroxine (neonatal T4) IVD, kit, fluorescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1700 FDA UDI
- Commercial Distribution
- 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
Category: Neonatal thyroxine (neonatal T4) IVD, kit, fluorescent immunoassay
GSP Neonatal Thyroxine (T4) 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 90d5b38f-380b-44bd-9305-a32052091956 36 fields · synced May 30, 2026