Identity
- Trade Name
- HardyCHROM™ FDA UDI
- Generic Name
- Multiple bacteria carbapenemase production IVD, kit, chromogenic FDA UDI
- Device Name
- HardyCHROM™ CRE, 15x100mm Plate, 18ml HardyCHROM™ CRE is a selective and differential chromogenic agar medium intended for the qualitative and presumptive detection from stool specimens of Escherichia coli that are non-susceptible to carbapenems as pink colonies and KES (Klebsiella aerogenes, Klebsiella oxytoca,Klebsiella pneumoniae, Enterobacter cloacae complex, and Serratia marcescens) that are non-susceptible to carbapenems as blue colonies. FDA UDI
- Model / Reference
- G323 FDA UDI
- Description
- HardyCHROM™ CRE, 15x100mm Plate, 18ml HardyCHROM™ CRE is a selective and differential chromogenic agar medium intended for the qualitative and presumptive detection from stool specimens of Escherichia coli that are non-susceptible to carbapenems as pink colonies and KES (Klebsiella aerogenes, Klebsiella oxytoca,Klebsiella pneumoniae, Enterobacter cloacae complex, and Serratia marcescens) that are non-susceptible to carbapenems as blue colonies. FDA UDI
Identifiers
- Catalog Number
- G323 FDA UDI
- Primary DI / UDI-DI
- 00816576025770 FDA UDI
- 510(k) Number
- K190553 FDA UDI
- FDA Product Code
- JSO FDA UDI
- GMDN Term
- Multiple bacteria carbapenemase production IVD, kit, chromogenic 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
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
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 bacteria carbapenemase production IVD, kit, chromogenic
HardyCHROM™ by Hardy Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple bacteria carbapenemase production IVD, kit, chromogenic.
- RAPIDEC® CARBA NP — BIOMERIEUX , INC. · Class II
- HardyCHROM™ — HARDY DIAGNOSTICS · Class II
Cleared under the same submission
K190553 also covers:
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
- Hardy Diagnostics
Sources (1)
- FDA UDI c78d3510-f1a5-45c0-9c3c-e9e8f5ba3137 37 fields · synced May 30, 2026