Identity
- Trade Name
- Stat Profile FDA UDI
- Generic Name
- Metabolic profile clinical chemistry analyser IVD, portable, semi-automated FDA UDI
- Device Name
- STAT PROFILE CRITICAL CARE XPRESS CO-OXIMETER CUVETTE WASHER KIT FDA UDI
- Model / Reference
- CCX CO-OX FDA UDI
- Description
- STAT PROFILE CRITICAL CARE XPRESS CO-OXIMETER CUVETTE WASHER KIT FDA UDI
Identifiers
- Catalog Number
- 38185 FDA UDI
- Primary DI / UDI-DI
- 00385480381857 FDA UDI
- 510(k) Number
- K061830 FDA UDI
- FDA Product Code
- CGA FDA UDICFA FDA UDIJIT FDA UDIJGS FDA UDIKHP FDA UDIJJY FDA UDICDS FDA UDIJFP FDA UDIJPK FDA UDIJKS FDA UDIJPI FDA UDICGZ FDA UDICHL FDA UDICGL FDA UDIJJS FDA UDIGHS FDA UDICEM FDA UDIJIX FDA UDICIG FDA UDIGKR FDA UDI
- GMDN Term
- Metabolic profile clinical chemistry analyser IVD, portable, semi-automated FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1345 FDA UDI862.1495 FDA UDI862.1150 FDA UDI862.1665 FDA UDI862.1450 FDA UDI862.1660 FDA UDI862.1770 FDA UDI862.1145 FDA UDI864.8625 FDA UDI862.3220 FDA UDI864.6400 FDA UDI862.1170 FDA UDI862.1120 FDA UDI862.1225 FDA UDI864.7425 FDA UDI862.1600 FDA UDI862.1110 FDA UDI864.5620 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
Yes
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, portable, semi-automated
Stat Profile by Nova Biomedical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Metabolic profile clinical chemistry analyser IVD, portable, semi-automated.
- NOVA — NOVA BIOMEDICAL CORPORATION · Class II
- NOVA — NOVA BIOMEDICAL CORPORATION · Class II
- STAT PROFILE — NOVA BIOMEDICAL CORPORATION · Class II
- NOVA — NOVA BIOMEDICAL CORPORATION · Class II
- NOVA — NOVA BIOMEDICAL CORPORATION · Class II
- Nova — NOVA BIOMEDICAL CORPORATION · Class II
- STAT PROFILE — NOVA BIOMEDICAL CORPORATION · Class II
- STAT PROFILE — NOVA BIOMEDICAL CORPORATION · Class II
Cleared under the same submission
K061830 also covers:
- STAT PROFILE — NOVA BIOMEDICAL CORPORATION
- STAT PROFILE — NOVA BIOMEDICAL CORPORATION
- STAT PROFILE — NOVA BIOMEDICAL CORPORATION
- STAT PROFILE — NOVA BIOMEDICAL CORPORATION
- STAT PROFILE — NOVA BIOMEDICAL CORPORATION
- STAT PROFILE — NOVA BIOMEDICAL CORPORATION
- STAT PROFILE — NOVA BIOMEDICAL CORPORATION
- STAT PROFILE — NOVA BIOMEDICAL CORPORATION
- STAT PROFILE — NOVA BIOMEDICAL CORPORATION
- STAT PROFILE — NOVA BIOMEDICAL CORPORATION
- STAT PROFILE — NOVA BIOMEDICAL CORPORATION
- STAT PROFILE — NOVA BIOMEDICAL CORPORATION
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
- Nova Biomedical Corporation
Sources (1)
- FDA UDI 3494fd1a-0f70-4f0e-a9d6-ae33e6638c57 37 fields · synced Jun 8, 2026