BD BBL™ Staphyloslide™ Latex Test Kit
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- BBL STAPHYLOSLIDE EUDAMEDBD BBL™ Staphyloslide™ Latex Test Kit FDA UDI
- Generic Name
- Staphylococcus aureus culture isolate antigen IVD, kit, agglutination FDA UDI
- Device Name
- BD BBL™ Staphyloslide™ Latex Test Kit EUDAMEDFDA UDI
- Model / Reference
- 240916 EUDAMEDFDA UDI
- Description
- BD BBL™ Staphyloslide™ Latex Test Kit FDA UDI
Identifiers
- Catalog Number
- 240916 FDA UDI
- Primary DI / UDI-DI
- 00382902409168 EUDAMEDFDA UDI
- Basic UDI-DI
- 038290QUHMNYFQML EUDAMED
- FDA Product Code
- GTN FDA UDI
- EMDN Code
- W0105011299 STAPHYLOCOCCI REAGENTS - OTHER EUDAMED
- GMDN Term
- Staphylococcus aureus culture isolate antigen IVD, kit, agglutination FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass I FDA UDI
- Regulation Number
- 866.3700 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
Yes
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 — 38 Milliliter FDA UDI
Category: Staphylococcus aureus culture isolate antigen IVD, kit, agglutination
BD BBL™ Staphyloslide™ 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 bdc5e101-a781-43a0-b5aa-7b60972bfe97 37 fields · synced Jul 25, 2026
- EUDAMED bcf29fe8-dcc8-4391-8a5a-7f2d135558cd 61 fields · synced Jul 25, 2026