BD BBL™ Streptocard™ Acid Latex Test Kit
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- BBL Streptocard EUDAMEDBD BBL™ Streptocard™ Acid Latex Test Kit FDA UDI
- Generic Name
- Beta-haemolytic Streptococcus serological grouping IVD, kit, agglutination FDA UDI
- Device Name
- BD BBL™ Streptocard™ Acid Latex Test Kit EUDAMEDBD BBL™ Streptocard™ Acid Latex Test Kit, 50 Tests FDA UDI
- Model / Reference
- 240917 EUDAMEDFDA UDI
- Description
- BD BBL™ Streptocard™ Acid Latex Test Kit, 50 Tests FDA UDI
Identifiers
- Catalog Number
- 240917 FDA UDI
- Primary DI / UDI-DI
- 00382902409175 EUDAMEDFDA UDI
- Basic UDI-DI
- 038290INMITSBFD4 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
Single Use
Yes
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
Yes
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Dimensions & Sizes
- Size
- Total Volume — 2.5 Milliliter FDA UDI
Category: Beta-haemolytic Streptococcus serological grouping IVD, kit, agglutination
BD BBL™ Streptocard™ Acid Latex Test Kit by Becton Dickinson And Company — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Becton Dickinson And Company
Sources (2)
- FDA UDI a03b5eab-44fb-4239-9d34-cd38b3be70c4 37 fields · synced Jul 15, 2026
- EUDAMED 5ec86b44-b9bd-4036-837b-766e1bb8d78b 61 fields · synced Jul 15, 2026