Identity
- Trade Name
- Stat Profile FDA UDI
- Generic Name
- Metabolic profile clinical chemistry analyser IVD, portable, semi-automated FDA UDI
- Device Name
- Stat Profile pHOx Ultra/CCX Capillary Tube 115 uL with Na Heparin 250 per Vial FDA UDI
- Model / Reference
- pHOx Ultra/CCX FDA UDI
- Description
- Stat Profile pHOx Ultra/CCX Capillary Tube 115 uL with Na Heparin 250 per Vial FDA UDI
Identifiers
- Catalog Number
- 48589 FDA UDI
- Primary DI / UDI-DI
- 00385480485890 FDA UDI
- 510(k) Number
- K110648 FDA UDI
- FDA Product Code
- CGA FDA UDICGZ FDA UDINGD FDA UDICGL FDA UDICFA FDA UDIJFP FDA UDIGHS FDA UDIGLY FDA UDIBXX FDA UDIJJB FDA UDICHL FDA UDIJIX FDA UDIJGS FDA UDICEM FDA UDICDS FDA UDIGKK FDA UDIGJC FDA UDIGGZ 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 UDI862.1170 FDA UDI862.1450 FDA UDI862.1225 FDA UDI862.1495 FDA UDI862.1145 FDA UDI864.7425 FDA UDI864.7500 FDA UDI868.2620 FDA UDI862.1115 FDA UDI862.1120 FDA UDI862.1150 FDA UDI862.1665 FDA UDI862.1600 FDA UDI862.1770 FDA UDI864.7490 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
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
K110648 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Nova Biomedical Corporation
Sources (1)
- FDA UDI 86a53277-7dd0-41f9-b5b9-455782d0cb98 36 fields · synced Jun 8, 2026