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BD BBL™ CHROMagar™ MRSA II / CHROMagar™ SA
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref MR502
Identity
- Trade Name
- CHROMagar™ MRSA EUDAMEDBD BBL™ CHROMagar™ MRSA II / CHROMagar™ SA FDA UDI
- Generic Name
- Differential/selective agar culture medium IVD FDA UDI
- Device Name
- CHROMagar™ MRSA EUDAMEDBD BBL™ CHROMagar™ MRSA II / CHROMagar™ SA FDA UDI
- Model / Reference
- MR502 EUDAMED215359 FDA UDI
- Description
- BD BBL™ CHROMagar™ MRSA II / CHROMagar™ SA FDA UDI
Identifiers
- Catalog Number
- 215359 FDA UDI
- Primary DI / UDI-DI
- 03760344760356 EUDAMED10382902153594 FDA UDI
- Basic UDI-DI
- 376034476MR50C6 EUDAMED
- 510(k) Number
- K092767 FDA UDI
- FDA Product Code
- JSO 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 II FDA UDI
- Regulation Number
- 866.1700 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- Not 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
Yes
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
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
No
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
- Outer Diameter — 100 Millimeter FDA UDIDepth — 15 Millimeter FDA UDI
BD BBL™ CHROMagar™ MRSA II / CHROMagar™ SA by Becton Dickinson And Company — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED
Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Becton Dickinson And Company
Sources (2)
- FDA UDI 63ed861b-540e-428b-b360-d27c5edee9d4 39 fields · synced Sep 17, 2026
- EUDAMED 2dda0128-f5d1-469e-ad1a-984d665334c8 61 fields · synced Sep 17, 2026