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 PLUS SENSOR MODULE REPLACEMENT FDA UDI
- Model / Reference
- PHOX PLUS FDA UDI
- Description
- STAT PROFILE pHOx PLUS SENSOR MODULE REPLACEMENT FDA UDI
Identifiers
- Catalog Number
- 27807 FDA UDI
- Primary DI / UDI-DI
- 00385480278072 FDA UDI
- 510(k) Number
- K002613 FDA UDI
- FDA Product Code
- CGA FDA UDIJIX FDA UDIGKR FDA UDIJFP FDA UDICGZ FDA UDICEM FDA UDIJPI FDA UDICHL FDA UDIGJS 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 UDI862.1150 FDA UDI864.5620 FDA UDI862.1145 FDA UDI862.1170 FDA UDI862.1600 FDA UDI864.6400 FDA UDI862.1120 FDA UDI864.7750 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, 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
K002613 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 2930c318-f6f6-4da2-b3d5-a1586f392530 37 fields · synced Jun 8, 2026