Identity
- Trade Name
- CHROMagar™ Staph aureus EUDAMEDBD BBL™ CHROMagar™ Staph aureus FDA UDI
- Generic Name
- Differential/selective agar culture medium IVD FDA UDI
- Device Name
- CHROMagar™ Staph aureus EUDAMEDBD BBL™ CHROMagar™ Staph aureus, Pkg. of 20 plates FDA UDI
- Model / Reference
- TA672 EUDAMED214982 FDA UDI
- Description
- BD BBL™ CHROMagar™ Staph aureus, Pkg. of 20 plates FDA UDI
Identifiers
- Catalog Number
- 214982 FDA UDI
- Primary DI / UDI-DI
- 03760344760363 EUDAMED10382902149825 FDA UDI
- Basic UDI-DI
- 376034476TA67BK EUDAMED
- FDA Product Code
- JSI FDA UDI
- EMDN Code
- W0104010101 DEHYDRATED CULTURE MEDIA (DCM) EUDAMED
- GMDN Term
- Differential/selective agar culture medium IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 866.2360 FDA UDI
- Market of Registration
- France 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
No
Microbial Substances
No
Reagent
No
Self Testing
No
Near-Patient Testing
No
Professional Testing
No
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Differential/selective agar culture medium IVD
BD BBL™ CHROMagar™ Staph aureus 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 66f59b7e-2c84-4e96-bcf2-c54e5c54618a 36 fields · synced Jul 11, 2026
- EUDAMED 473d2d94-1c4d-4a17-8ed5-4e439bb76532 61 fields · synced Jul 11, 2026