Identity
- Trade Name
- HardyCHROM™ FDA UDI
- Generic Name
- Differential/selective agar culture medium IVD FDA UDI
- Device Name
- HardyCHROM™ Campy Agar, 15x100mm plate, 10/pk. Screening medium for the selective isolation and chromogenic differentiation of Campylobacter jejuni, C.lari, C.coli, and C.fetus from direct stool cultures, or from food or poultry samples. Some ingredients are very light sensitive. Store and incubate media in the dark. FDA UDI
- Model / Reference
- G339 FDA UDI
- Description
- HardyCHROM™ Campy Agar, 15x100mm plate, 10/pk. Screening medium for the selective isolation and chromogenic differentiation of Campylobacter jejuni, C.lari, C.coli, and C.fetus from direct stool cultures, or from food or poultry samples. Some ingredients are very light sensitive. Store and incubate media in the dark. FDA UDI
Identifiers
- Catalog Number
- G339 FDA UDI
- Primary DI / UDI-DI
- 00819398020541 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
No
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 771c0c81-79a4-4124-bb4a-34734782fd58 36 fields · synced May 29, 2026