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Alere Cholestech LDX®

FDA UDI

Class II (US FDA UDI)

by Alere San Diego, Inc.

Identity

Trade Name
Alere Cholestech LDX® FDA UDI
Generic Name
Multiple lipid analyte IVD, reagent FDA UDI
Device Name
Alere Cholestech LDX® Lipid Profile GLU FDA UDI
Model / Reference
14-531 FDA UDI
Description
Alere Cholestech LDX® Lipid Profile GLU FDA UDI

Identifiers

Catalog Number
14-531 FDA UDI
Primary DI / UDI-DI
04571226470831 FDA UDI
FDA Product Code
CGA FDA UDI
JGY FDA UDI
LBS FDA UDI
CHH FDA UDI
GMDN Term
Multiple lipid analyte IVD, reagent FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1345 FDA UDI
862.1705 FDA UDI
862.1475 FDA UDI
862.1175 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

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 lipid analyte IVD, reagent

Alere Cholestech LDX® by Alere San Diego, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple lipid analyte IVD, reagent.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Alere San Diego, Inc.

Sources (1)

  • FDA UDI 2ae037a3-48c7-4218-bba6-8d6173e87156 36 fields · synced Jun 9, 2026