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Nova Max

FDA UDI

Class II (US FDA UDI)

by Nova Biomedical Corporation

Identity

Trade Name
Nova Max FDA UDI
Generic Name
Multiple clinical chemistry analyte monitoring system IVD, home-use FDA UDI
Device Name
Nova Max Plus Blood Glucose Monitoring System FDA UDI
Model / Reference
Plus FDA UDI
Description
Nova Max Plus Blood Glucose Monitoring System FDA UDI

Identifiers

Catalog Number
45824 FDA UDI
Primary DI / UDI-DI
00385480458245 FDA UDI
FDA Product Code
NBW FDA UDI
JJX FDA UDI
JIN FDA UDI
CGA FDA UDI
GMDN Term
Multiple clinical chemistry analyte monitoring system IVD, home-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1345 FDA UDI
862.1660 FDA UDI
862.1435 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

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

Yes

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Multiple clinical chemistry analyte monitoring system IVD, home-use

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

Similar devices

Also classified as Multiple clinical chemistry analyte monitoring system IVD, home-use.

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 886d35ac-39f3-4b89-8d4b-495ab5a4a7ef 36 fields · synced Jun 8, 2026