Identity
- Trade Name
- HardyCHROM™ FDA UDI
- Generic Name
- MRSA agar culture medium IVD, chromogenic FDA UDI
- Device Name
- HardyCHROM™ MRSA - RSR A selective and differential chromogenic medium for the qualitative direct detection of nasal colonization by methicillin-resistant Staph aureus (MRSA). Not intended to diagnose infection or guide therapy. Further testing required for susceptibility or typing. LIGHT SENSITIVE. FDA UDI
- Model / Reference
- GA307 FDA UDI
- Description
- HardyCHROM™ MRSA - RSR A selective and differential chromogenic medium for the qualitative direct detection of nasal colonization by methicillin-resistant Staph aureus (MRSA). Not intended to diagnose infection or guide therapy. Further testing required for susceptibility or typing. LIGHT SENSITIVE. FDA UDI
Identifiers
- Catalog Number
- GA307 FDA UDI
- Primary DI / UDI-DI
- 00816576020096 FDA UDI
- 510(k) Number
- K102922 FDA UDI
- FDA Product Code
- JSO FDA UDI
- GMDN Term
- MRSA agar culture medium IVD, 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
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: MRSA agar culture medium IVD, chromogenic
HardyCHROM™ by Hardy Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as MRSA agar culture medium IVD, chromogenic.
- Select — Bio-Rad · Class II
- Select — Bio-Rad · Class II
- HardyCHROM™ — HARDY DIAGNOSTICS · Class II
Cleared under the same submission
K102922 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 2c995a31-0f8e-4868-8869-662ae43711fd 37 fields · synced May 30, 2026