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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/M/ULTRA CAPILLARY TUBE KIT: 250uL WITH Li HEPARIN FDA UDI
Model / Reference
ULTRA FDA UDI
Description
STAT PROFILE/M/ULTRA CAPILLARY TUBE KIT: 250uL WITH Li HEPARIN FDA UDI

Identifiers

Catalog Number
11533 FDA UDI
Primary DI / UDI-DI
00385480115339 FDA UDI
FDA Product Code
CEM FDA UDI
JFP FDA UDI
CGZ FDA UDI
CDS FDA UDI
JIX FDA UDI
KHP FDA UDI
JPI FDA UDI
JJY FDA UDI
JKS FDA UDI
JGS FDA UDI
CFA FDA UDI
CHL FDA UDI
GMDN Term
Metabolic profile clinical chemistry analyser IVD, portable, semi-automated FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1600 FDA UDI
862.1145 FDA UDI
862.1170 FDA UDI
862.1770 FDA UDI
862.1150 FDA UDI
862.1450 FDA UDI
864.6400 FDA UDI
862.1660 FDA UDI
862.3220 FDA UDI
862.1665 FDA UDI
862.1495 FDA UDI
862.1120 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.

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 88702be7-0861-4528-b990-cf8ccab98d7d 36 fields · synced Jun 6, 2026