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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 16 GLUCOSE MEMBRANE KIT: REFRIGERATE FDA UDI
Model / Reference
16 FDA UDI
Description
NOVA 16 GLUCOSE MEMBRANE KIT: REFRIGERATE FDA UDI

Identifiers

Catalog Number
16483 FDA UDI
Primary DI / UDI-DI
00385480164832 FDA UDI
510(k) Number
K963005 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

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.

Cleared under the same submission

K963005 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 90ad0b2b-428f-4bf4-827c-849e7432b4fb 37 fields · synced Jun 8, 2026