Identity
- Trade Name
- BBL EUDAMEDBD BBL™ Streptocard™ Enzyme Test Latex A FDA UDI
- Generic Name
- Beta-haemolytic Streptococcus serological grouping IVD, kit, agglutination FDA UDI
- Device Name
- BD BBL™ Streptocard™ Enzyme Test Latex A EUDAMEDBD BBL™ Streptocard™ Enzyme Test Latex A, one 2.5 mL bottle FDA UDI
- Model / Reference
- 240958 EUDAMEDFDA UDI
- Description
- BD BBL™ Streptocard™ Enzyme Test Latex A, one 2.5 mL bottle FDA UDI
Identifiers
- Catalog Number
- 240958 FDA UDI
- Primary DI / UDI-DI
- 00382902409588 EUDAMEDFDA UDI
- Basic UDI-DI
- 038290GYMSVFYGMT EUDAMED
- FDA Product Code
- GTZ FDA UDI
- EMDN Code
- W0105011199 STREPTOCOCCAL REAGENTS - OTHER EUDAMED
- GMDN Term
- Beta-haemolytic Streptococcus serological grouping IVD, kit, agglutination FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass I FDA UDI
- Regulation Number
- 866.3740 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
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
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
Dimensions & Sizes
- Size
- Total Volume — 2.5 Milliliter FDA UDI
Bbl by Becton, Dickinson and Company — Class B — 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 | 038290GYMSVFYGMT | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
- EUDAMED SRN
- US-MF-000018910
- Authorised Representative
- Becton Dickinson Ireland Limited IE-AR-000007610
Sources (2)
- EUDAMED c6887d6e-6fb4-4599-8913-6d4eef04870f 61 fields · synced Jun 9, 2026
- FDA UDI 256c774c-d92f-4085-88c3-c9ffd4f91eb4 37 fields · synced May 30, 2026