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Stat Profile

FDA UDI

Class II (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 PLUS/PLUS C GLUCOSE MEMBRANE FDA UDI
Model / Reference
PLUS/PLUS C FDA UDI
Description
STAT PROFILE pHOx PLUS/PLUS C GLUCOSE MEMBRANE FDA UDI

Identifiers

Catalog Number
28969 FDA UDI
Primary DI / UDI-DI
00385480289696 FDA UDI
510(k) Number
K002613 FDA UDI
FDA Product Code
CGA FDA UDI
GMDN Term
Metabolic profile clinical chemistry analyser IVD, portable, semi-automated FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1345 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 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.

Cleared under the same submission

K002613 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nova Biomedical Corporation

Sources (1)

  • FDA UDI dd8ebcb0-1daa-4cfc-b3c5-bfb1a396b235 37 fields · synced Jun 8, 2026