Identity
- Trade Name
- STAT PROFILE FDA UDI
- Generic Name
- Metabolic profile clinical chemistry analyser IVD, portable, semi-automated FDA UDI
- Device Name
- Prime Sensor Card CCS (High Volume) FDA UDI
- Model / Reference
- PRIME CCS FDA UDI
- Description
- Prime Sensor Card CCS (High Volume) FDA UDI
Identifiers
- Catalog Number
- 55263 FDA UDI
- Primary DI / UDI-DI
- 00385480552639 FDA UDI
- 510(k) Number
- K141907 FDA UDI
- FDA Product Code
- GKF FDA UDIJFP FDA UDICGZ FDA UDIJJS FDA UDICEM FDA UDIJGS FDA UDICHL FDA UDIKHP FDA UDICGA FDA UDIJIX FDA UDI
- GMDN Term
- Metabolic profile clinical chemistry analyser IVD, portable, semi-automated FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.5600 FDA UDI862.1145 FDA UDI862.1170 FDA UDI862.1660 FDA UDI862.1600 FDA UDI862.1665 FDA UDI862.1120 FDA UDI862.1450 FDA UDI862.1345 FDA UDI862.1150 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
K141907 also covers:
- NOVA — NOVA BIOMEDICAL CORPORATION
- Nova — 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 c182d62b-e1c9-4e68-b220-6af4f32ae3d5 37 fields · synced Jun 8, 2026