Identity
- Trade Name
- STAT PROFILE FDA UDI
- Generic Name
- Multiple blood gas/haemoximetry/electrolyte analyte IVD, control FDA UDI
- Device Name
- Prime Auto QC Cartridge CCS 200 Sample FDA UDI
- Model / Reference
- PRIME CCS FDA UDI
- Description
- Prime Auto QC Cartridge CCS 200 Sample FDA UDI
Identifiers
- Catalog Number
- 45150 FDA UDI
- Primary DI / UDI-DI
- 00385480451505 FDA UDI
- 510(k) Number
- K141907 FDA UDI
- FDA Product Code
- JJY FDA UDI
- GMDN Term
- Multiple blood gas/haemoximetry/electrolyte analyte IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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: Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
Stat Profile by Nova Biomedical Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple blood gas/haemoximetry/electrolyte analyte IVD, control.
- Meter Trax — Bio-Rad Laboratories · Class I
- RANGE+ QUALICHECK LEV. 1 S7930 — Radiometer Medical ApS · Class I
- Avox-4 CO-Oximeter Control - L2 — INSTRUMENTATION LABORATORY COMPANY · Class I
- i-STAT — Abbott Point of Care Inc. · Class I
- RAPIDSystems™ AutomaticQC Cartridge — Siemens Healthcare Diagnostics · Class II
- Bi-Level Quality Control Kit — Medica Corp. · Class II
- HIGH METABOLITE QC, LEVEL 1 — Radiometer Medical ApS · Class I
- GEM System Evaluator 1 — INSTRUMENTATION LABORATORY COMPANY · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Nova Biomedical Corporation
Sources (1)
- FDA UDI 5a6adb38-3afa-4c05-8370-cc25e21b1db4 37 fields · synced Jun 8, 2026