← Back to catalogue

Nova

FDA UDI

Class II (US FDA UDI)

by Nova Biomedical Corporation

Identity

Trade Name
NOVA FDA UDI
Generic Name
Metabolic profile clinical chemistry analyser IVD, portable, semi-automated FDA UDI
Device Name
NOVA 1/5/8/10/11/13/14 SENSOR SPACER FDA UDI
Model / Reference
1/5/8/10/11/13/14 FDA UDI
Description
NOVA 1/5/8/10/11/13/14 SENSOR SPACER FDA UDI

Identifiers

Catalog Number
13203 FDA UDI
Primary DI / UDI-DI
00385480132039 FDA UDI
FDA Product Code
NDW FDA UDI
CDS FDA UDI
JGS FDA UDI
CGZ FDA UDI
JFP FDA UDI
CHL FDA UDI
CFA FDA UDI
CGA FDA UDI
JPI FDA UDI
CEM FDA UDI
GMDN Term
Metabolic profile clinical chemistry analyser IVD, portable, semi-automated FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.3560 FDA UDI
862.1770 FDA UDI
862.1665 FDA UDI
862.1170 FDA UDI
862.1145 FDA UDI
862.1120 FDA UDI
862.1495 FDA UDI
862.1345 FDA UDI
864.6400 FDA UDI
862.1600 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

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

Nova 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

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

Manufacturer

Manufacturer
Nova Biomedical Corporation

Sources (1)

  • FDA UDI ea72bf92-6b7f-4e4e-bb40-c2144821e0b4 36 fields · synced Jun 8, 2026