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 W/R TUBING HARNESS FDA UDI
- Model / Reference
- PHOX ULTRA W/R FDA UDI
- Description
- STAT PROFILE PHOX ULTRA W/R TUBING HARNESS FDA UDI
Identifiers
- Catalog Number
- 48561 FDA UDI
- Primary DI / UDI-DI
- 00385480485616 FDA UDI
- 510(k) Number
- K110648 FDA UDI
- FDA Product Code
- GJC FDA UDIGGZ FDA UDIGKK FDA UDICGA FDA UDIGLY FDA UDICDS FDA UDICGZ FDA UDINGD FDA UDICGL FDA UDIGHS FDA UDICFA FDA UDICHL FDA UDIBXX FDA UDIJIX FDA UDICEM FDA UDIJFP FDA UDIJJB FDA UDIJGS FDA UDI
- GMDN Term
- Metabolic profile clinical chemistry analyser IVD, portable, semi-automated FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7490 FDA UDI864.7500 FDA UDI862.1345 FDA UDI862.1770 FDA UDI862.1170 FDA UDI862.1450 FDA UDI862.1225 FDA UDI864.7425 FDA UDI862.1495 FDA UDI862.1120 FDA UDI868.2620 FDA UDI862.1150 FDA UDI862.1600 FDA UDI862.1145 FDA UDI862.1115 FDA UDI862.1665 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
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 |
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Manufacturer
- Manufacturer
- Nova Biomedical Corporation
Sources (1)
- FDA UDI 8d98309b-24e2-43b4-a282-11d9c9dc1df6 37 fields · synced Jun 8, 2026