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AimStrip Tandem Lipid Profile and glucose measuring system

FDA UDI

Class II (US FDA UDI)

by Germaine Laboratories, Inc.

Identity

Trade Name
AimStrip Tandem Lipid Profile and glucose measuring system FDA UDI
Generic Name
Glucose/ketone/lipid profile IVD, kit, enzyme chemiluminescence FDA UDI
Device Name
Lipid and Glucose Measuring System FDA UDI
Model / Reference
ILM-0001A FDA UDI
Description
Lipid and Glucose Measuring System FDA UDI

Identifiers

Primary DI / UDI-DI
00695684773014 FDA UDI
FDA Product Code
CGA FDA UDI
JJX FDA UDI
CHH FDA UDI
JGY FDA UDI
GMDN Term
Glucose/ketone/lipid profile IVD, kit, enzyme chemiluminescence FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1345 FDA UDI
862.1660 FDA UDI
862.1175 FDA UDI
862.1705 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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Glucose IVD, kit, electrometryGlucose IVD, controlTotal cholesterol lipid IVD, kit, spectrophotometryTriglyceride IVD, kit, spectrophotometry

AimStrip Tandem Lipid Profile and glucose measuring system by Germaine Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Triglyceride IVD, control.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Germaine Laboratories, Inc.

Sources (1)

  • FDA UDI 4efcb199-ffff-49f3-97c5-f29659b56c41 34 fields · synced May 31, 2026