Identity
- Trade Name
- BD Tritest FDA UDI
- Generic Name
- Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) FDA UDI
- Device Name
- Tritest CD3 FITC/CD4 PE/CD45 PerCP IVD FDA UDI
- Model / Reference
- 340383 FDA UDI
- Description
- Tritest CD3 FITC/CD4 PE/CD45 PerCP IVD FDA UDI
Identifiers
- Catalog Number
- 340383 FDA UDI
- Primary DI / UDI-DI
- 00382903403837 FDA UDI
- FDA Product Code
- GKZ FDA UDI
- GMDN Term
- Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.5220 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
BD Tritest by Becton Dickinson And Company — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow).
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- Simultest — BECTON DICKINSON AND COMPANY · Class II
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- BD Tritest — BECTON DICKINSON AND COMPANY · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Becton Dickinson And Company
Sources (2)
- FDA UDI e2068587-aa9b-4d27-a6f9-0799e8a3f124 36 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 4, 2026