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 Replacement Gasket Kit Flow- Through Sensor FDA UDI
- Model / Reference
- PHOX ULTRA/CCX FDA UDI
- Description
- Stat Profile pHOx Ultra/CCX Replacement Gasket Kit Flow- Through Sensor FDA UDI
Identifiers
- Catalog Number
- 48584 FDA UDI
- Primary DI / UDI-DI
- 00385480485845 FDA UDI
- 510(k) Number
- K110648 FDA UDI
- FDA Product Code
- BXX FDA UDINGD FDA UDIJFP FDA UDIGLY FDA UDIGKK FDA UDICGA FDA UDICHL FDA UDICDS FDA UDICEM FDA UDIJIX FDA UDIGGZ FDA UDIGJC FDA UDICFA FDA UDIJJB FDA UDIGHS FDA UDIJGS FDA UDICGZ FDA UDICGL FDA UDI
- GMDN Term
- Metabolic profile clinical chemistry analyser IVD, portable, semi-automated FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.2620 FDA UDI862.1450 FDA UDI862.1145 FDA UDI864.7500 FDA UDI862.1345 FDA UDI862.1120 FDA UDI862.1770 FDA UDI862.1600 FDA UDI862.1150 FDA UDI864.7490 FDA UDI862.1495 FDA UDI862.1115 FDA UDI864.7425 FDA UDI862.1665 FDA UDI862.1170 FDA UDI862.1225 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 I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Nova Biomedical Corporation
Sources (1)
- FDA UDI 54583097-1242-4666-bd08-60c6447459f5 37 fields · synced Jun 8, 2026