Identity
- Trade Name
- Stat Profile FDA UDI
- Generic Name
- Metabolic profile clinical chemistry analyser IVD FDA UDI
- Device Name
- Stat Profile CCX Reference Sensor FDA UDI
- Model / Reference
- CCX FDA UDI
- Description
- Stat Profile CCX Reference Sensor FDA UDI
Identifiers
- Catalog Number
- 37959 FDA UDI
- Primary DI / UDI-DI
- 00385480379595 FDA UDI
- 510(k) Number
- K020297 FDA UDI
- FDA Product Code
- CGZ FDA UDIKHP FDA UDIJGS FDA UDICEM FDA UDIJIX FDA UDIJPK FDA UDIGKR FDA UDIGHS FDA UDICGA FDA UDICDS FDA UDIJFP FDA UDIJPI FDA UDICHL FDA UDICGL FDA UDIJKS FDA UDIJJS FDA UDICFA FDA UDI
- GMDN Term
- Metabolic profile clinical chemistry analyser IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1170 FDA UDI862.1450 FDA UDI862.1665 FDA UDI862.1600 FDA UDI862.1150 FDA UDI864.8625 FDA UDI864.5620 FDA UDI864.7425 FDA UDI862.1345 FDA UDI862.1770 FDA UDI862.1145 FDA UDI864.6400 FDA UDI862.1120 FDA UDI862.1225 FDA UDI862.3220 FDA UDI862.1660 FDA UDI862.1495 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Category: Metabolic profile clinical chemistry analyser IVD
Stat Profile by Nova Biomedical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K020297 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Nova Biomedical Corporation
Sources (1)
- FDA UDI 805d9b4a-3a8a-4ea9-b4f3-886d9696ff5f 37 fields · synced Jun 8, 2026