Identity
- Trade Name
- BD MULTITEST EUDAMEDBD Multitest™ FDA UDI
- Generic Name
- Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) FDA UDI
- Device Name
- BD Multitest™ 6-Color TBNK with BD Trucount™ Tubes EUDAMEDBD Multitest 6-Color TBNK Kit W/Trucount FDA UDI
- Model / Reference
- 337166 EUDAMEDFDA UDI
- Description
- BD Multitest 6-Color TBNK Kit W/Trucount FDA UDI
Identifiers
- Catalog Number
- 337166 FDA UDI
- Primary DI / UDI-DI
- 00382903371662 EUDAMEDFDA UDI
- Basic UDI-DI
- 038290AGTTMGMZA5 EUDAMED
- FDA Product Code
- GKZ FDA UDI
- EMDN Code
- W0103080101 ANTIBODIES FOR B AND T-CELL SUBTYPING EUDAMED
- GMDN Term
- Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass II FDA UDI
- Regulation Number
- 864.5220 FDA UDI
- Market of Registration
- Bulgaria EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
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
Bd Multitest by Becton, Dickinson and Company, BD Biosciences — Class C — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 038290AGTTMGMZA5 | Class C | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class C | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Becton, Dickinson and Company, BD Biosciences
- EUDAMED SRN
- US-MF-000017797
- Authorised Representative
- Becton Dickinson Ireland Limited IE-AR-000007610
Sources (3)
- EUDAMED c492cb63-a774-4e4b-b93b-892a44fa2034 61 fields · synced Jul 9, 2026
- FDA UDI 708c99ca-9603-4477-b961-3ea7c6ca8932 37 fields · synced May 30, 2026
- EUDAMED 0da4374a-3995-4270-8682-9722c15f8c2c 61 fields · synced Jul 9, 2026