Identity
- Trade Name
- HardyCHROM FDA UDI
- Generic Name
- Differential/selective agar culture medium IVD FDA UDI
- Device Name
- HardyCHROM Candida + auris Recommended for the selective isolation and differential identification of yeast. The medium allows for the differentiation of C. albicans , C. tropicalis, C. krusei, and C. auris based on colony morphology, color, and positive UV fluorescence. This medium facilitates the detection of mixed yeast cultures. FDA UDI
- Model / Reference
- G343 FDA UDI
- Description
- HardyCHROM Candida + auris Recommended for the selective isolation and differential identification of yeast. The medium allows for the differentiation of C. albicans , C. tropicalis, C. krusei, and C. auris based on colony morphology, color, and positive UV fluorescence. This medium facilitates the detection of mixed yeast cultures. FDA UDI
Identifiers
- Catalog Number
- G343 FDA UDI
- Primary DI / UDI-DI
- 00816576023370 FDA UDI
- FDA Product Code
- JSI FDA UDI
- GMDN Term
- Differential/selective agar culture medium IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.2360 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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Differential/selective agar culture medium IVD
HardyCHROM by Hardy Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Hardy Diagnostics
Sources (1)
- FDA UDI 4e5f1eec-cb61-4f50-b329-4ccb74e314b6 36 fields · synced Jun 6, 2026