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Statstrip

FDA UDI

Class II (US FDA UDI)

by Nova Biomedical Corporation

Identity

Trade Name
STATSTRIP FDA UDI
Generic Name
Glucose monitoring system IVD, point-of-care FDA UDI
Device Name
StatStrip GLU Meter with Quick Reference Guide Remanufactured FDA UDI
Model / Reference
1.0 FDA UDI
Description
StatStrip GLU Meter with Quick Reference Guide Remanufactured FDA UDI

Identifiers

Catalog Number
51707 FDA UDI
Primary DI / UDI-DI
00385480517072 FDA UDI
FDA Product Code
CGA FDA UDI
JJX FDA UDI
GMDN Term
Glucose monitoring system IVD, point-of-care FDA UDI

Classification

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

No

FDA UDI

Category: Glucose monitoring system IVD, point-of-care

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

Similar devices

Also classified as Glucose monitoring system IVD, point-of-care.

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 fe34b985-44f1-4003-b796-8b9568817598 36 fields · synced Jun 8, 2026