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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
Multichannel clinical chemistry analyser IVD, point-of-care, line-powered FDA UDI
Device Name
Prime ES Plus W/ Scanner FDA UDI
Model / Reference
Prime ES Plus FDA UDI
Description
Prime ES Plus W/ Scanner FDA UDI

Identifiers

Catalog Number
62341 FDA UDI
Primary DI / UDI-DI
00385480623414 FDA UDI
FDA Product Code
CHL FDA UDI
GMDN Term
Multichannel clinical chemistry analyser IVD, point-of-care, line-powered FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1120 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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Multichannel clinical chemistry analyser IVD, point-of-care, line-powered

Stat Profile by Nova Biomedical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multichannel clinical chemistry analyser IVD, point-of-care, line-powered.

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 7a7c2aec-6173-44d3-800c-9b11a606cb3e 36 fields · synced Jun 8, 2026