Identity
- Trade Name
- Mouse anti-AFP (ZSA06) Concentrate FDA UDI
- Generic Name
- Multiple solid tumour differentiation marker IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Model / Reference
- 180003 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10190302007832 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Multiple solid tumour differentiation marker IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.1860 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple solid tumour differentiation marker IVD, kit, enzyme immunoassay (EIA)
Mouse anti-AFP (ZSA06) Concentrate by Life Technologies Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple solid tumour differentiation marker IVD, kit, enzyme immunoassay (EIA).
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 I | Pending data |
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Manufacturer
- Manufacturer
- Life Technologies Limited
Sources (1)
- FDA UDI e877b8a6-d89b-4576-b1af-8d938514b528 32 fields · synced May 29, 2026