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Alere Cholestech LDX®

FDA UDI

Class I (US FDA UDI)

by Alere San Diego, Inc.

Identity

Trade Name
Alere Cholestech LDX® FDA UDI
Generic Name
Glucose/ketone/lipid profile IVD, kit, enzyme spectrophotometry FDA UDI
Device Name
Alere Cholestech LDX® Lipid Profile FDA UDI
Model / Reference
99020 FDA UDI
Description
Alere Cholestech LDX® Lipid Profile FDA UDI

Identifiers

Catalog Number
99020 FDA UDI
Primary DI / UDI-DI
00899722002337 FDA UDI
FDA Product Code
JGY FDA UDI
LBS FDA UDI
CHH FDA UDI
GMDN Term
Glucose/ketone/lipid profile IVD, kit, enzyme spectrophotometry FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
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: Glucose/ketone/lipid profile IVD, kit, enzyme spectrophotometry

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

Similar devices

Also classified as Glucose/ketone/lipid profile IVD, kit, enzyme spectrophotometry.

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 f478be02-1880-41e3-9496-b299276a1ff7 36 fields · synced Jun 9, 2026