← Back to catalogue

Stat Profile

FDA UDI

Class I (US FDA UDI)

by Nova Biomedical Corporation

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 Lactate Sensor FDA UDI
Model / Reference
ULTRA/CCX FDA UDI
Description
Stat Profile pHOx Ultra/CCX Lactate Sensor FDA UDI

Identifiers

Catalog Number
48553 FDA UDI
Primary DI / UDI-DI
00385480485531 FDA UDI
510(k) Number
K110648 FDA UDI
FDA Product Code
KHP FDA UDI
GMDN Term
Metabolic profile clinical chemistry analyser IVD, portable, semi-automated FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1450 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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.

Cleared under the same submission

K110648 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Nova Biomedical Corporation

Sources (1)

  • FDA UDI 809e1bb5-a5c4-4a4b-a60b-f6f3133f9e37 37 fields · synced Jun 8, 2026