Identity
- Trade Name
- Human CD3 TRI-COLOR® Conjugate FDA UDI
- Generic Name
- CD3 cell marker IVD, antibody FDA UDI
- Model / Reference
- MHCD03065 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10190302005401 FDA UDI
- 510(k) Number
- K944127 FDA UDI
- FDA Product Code
- GKZ FDA UDI
- GMDN Term
- CD3 cell marker IVD, antibody FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.5220 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Human CD3 TRI-COLOR® Conjugate by Life Technologies Limited — 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
- Life Technologies Limited
Sources (1)
- FDA UDI b72332af-f53e-4ec7-bcec-05265672c883 34 fields · synced May 30, 2026