Aimstrip Plus, Glucose Control Solution

FDA UDI

Class II (US FDA UDI)

by Germaine Laboratories, Inc.

Identity

Trade Name: AIMSTRIP PLUS, GLUCOSE CONTROL SOLUTION FDA UDI
Generic Name: Glucose IVD, control FDA UDI
Device Name: Blood glucose control solution for use with AimStrip® Plus Blood Glucose Test Strips & meter for testing blood glucose levels FDA UDI
Model / Reference: 37312 FDA UDI
Description: Blood glucose control solution for use with AimStrip® Plus Blood Glucose Test Strips & meter for testing blood glucose levels FDA UDI

Identifiers

Primary DI / UDI-DI: 00695684373122 FDA UDI
FDA Product Code: NBW FDA UDI
JJX FDA UDI
GMDN Term: Glucose IVD, control 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

Yes

FDA UDI

Over-the-Counter

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

FDA UDI

Category: Glucose IVD, control

Aimstrip Plus, Glucose Control Solution by Germaine Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Germaine Laboratories, Inc.

Sources (1)

FDA UDI 30a29291-fb99-4a6b-b7e9-3072807d5af8 33 fields · synced Jun 6, 2026