MedSource Glucometer Test Solution (Normal, high)

FDA UDI

Class II (US FDA UDI)

by Medsource International Llc

Identity

Trade Name: MedSource Glucometer Test Solution (Normal, high) FDA UDI
Generic Name: Glucose monitoring system IVD, home-use FDA UDI
Device Name: Glucometer Test Solution (Normal, high) FDA UDI
Model / Reference: MS-76016 FDA UDI
Description: Glucometer Test Solution (Normal, high) FDA UDI

Identifiers

Primary DI / UDI-DI: 00816703021927 FDA UDI
510(k) Number: K082965 FDA UDI
FDA Product Code: CGA FDA UDI
JJX FDA UDI
NBW FDA UDI
GMDN Term: Glucose monitoring system IVD, home-use 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Glucose monitoring system IVD, home-use

MedSource Glucometer Test Solution (Normal, high) by Medsource International Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K082965 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Medsource International Llc

Sources (1)

FDA UDI 37ad1933-1793-4343-a37d-221577920bd2 34 fields · synced May 30, 2026