Identity
- Trade Name
- chromID™ MRSA /SAID FDA UDI
- Generic Name
- Multiple formulation agar culture medium IVD FDA UDI
- Device Name
- Chromogenic medium for the screening and qualitative detection of methicillin-resistant Staphylococcus aureus and selective isolation of staphylococci and the direct identification of S. aureus. FDA UDI
- Model / Reference
- chromID™ MRSA /SAID FDA UDI
- Description
- Chromogenic medium for the screening and qualitative detection of methicillin-resistant Staphylococcus aureus and selective isolation of staphylococci and the direct identification of S. aureus. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03573026552091 FDA UDI
- FDA Product Code
- JSO FDA UDI
- GMDN Term
- Multiple formulation agar culture medium IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.1700 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Multiple formulation agar culture medium IVD
chromID™ MRSA /SAID by Biomerieux , Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- HardyCHROM™ — HARDY DIAGNOSTICS · Class II
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- Uricult® CLED/MacConkey — Aidian Oy · Class I
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Biomerieux , Inc.
Sources (1)
- FDA UDI 06e8cd8d-c755-48ed-9b57-b1fb33121444 35 fields · synced May 30, 2026