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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 Critical Care Express Analyzer FDA UDI
Model / Reference
CCX FDA UDI
Description
Stat Profile Critical Care Express Analyzer FDA UDI

Identifiers

Catalog Number
35942 FDA UDI
Primary DI / UDI-DI
00385480359429 FDA UDI
510(k) Number
K013729 FDA UDI
FDA Product Code
CGZ FDA UDI
JPK FDA UDI
CGL FDA UDI
CHL FDA UDI
CDS FDA UDI
GKR FDA UDI
JGS FDA UDI
JFP FDA UDI
CGA FDA UDI
CFA FDA UDI
CEM FDA UDI
JKS FDA UDI
GHS FDA UDI
JIX FDA UDI
JJS FDA UDI
KHP FDA UDI
JPI FDA UDI
GMDN Term
Metabolic profile clinical chemistry analyser IVD, portable, semi-automated FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1170 FDA UDI
864.8625 FDA UDI
862.1225 FDA UDI
862.1120 FDA UDI
862.1770 FDA UDI
864.5620 FDA UDI
862.1665 FDA UDI
862.1145 FDA UDI
862.1345 FDA UDI
862.1495 FDA UDI
862.1600 FDA UDI
862.3220 FDA UDI
864.7425 FDA UDI
862.1150 FDA UDI
862.1660 FDA UDI
862.1450 FDA UDI
864.6400 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

No

FDA UDI

Serial Number

Yes

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

K013729 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 02af949a-7b31-4cf5-a7a2-750f6a20e469 37 fields · synced Jun 8, 2026