← Back to catalogue

Cholestech LDX™

FDA UDI

Class I (US FDA UDI)

by Alere San Diego, Inc.

Identity

Trade Name
Cholestech LDX™ FDA UDI
Generic Name
Multiple lipid analyte IVD, reagent FDA UDI
Device Name
Cholestech LDX™ TC FDA UDI
Model / Reference
97986 FDA UDI
Description
Cholestech LDX™ TC FDA UDI

Identifiers

Catalog Number
97986 FDA UDI
Primary DI / UDI-DI
00893038002883 FDA UDI
510(k) Number
K223179 FDA UDI
FDA Product Code
CHH FDA UDI
GMDN Term
Multiple lipid analyte IVD, reagent FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
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

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

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Multiple lipid analyte IVD, reagent

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

Similar devices

Also classified as Multiple lipid analyte IVD, reagent.

Cleared under the same submission

K223179 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Alere San Diego, Inc.

Sources (1)

  • FDA UDI d8f8681f-a945-449c-90f6-94dd6967afec 37 fields · synced Jun 9, 2026