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Cholestech LDX™

FDA UDI

Class I (US FDA UDI)

by Alere San Diego, Inc.

Identity

Trade Name
Cholestech LDX™ FDA UDI
Generic Name
Photometric/spectroscopic immunoassay analyser IVD FDA UDI
Device Name
Cholestech LDX™ Analyzer FDA UDI
Model / Reference
14874 FDA UDI
Description
Cholestech LDX™ Analyzer FDA UDI

Identifiers

Catalog Number
14874MR FDA UDI
Primary DI / UDI-DI
00810039380512 FDA UDI
510(k) Number
K223179 FDA UDI
FDA Product Code
JJF FDA UDI
GMDN Term
Photometric/spectroscopic immunoassay analyser IVD FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.2170 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

Yes

FDA UDI

Category: Photometric/spectroscopic immunoassay analyser IVD

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

Similar devices

Also classified as Photometric/spectroscopic immunoassay analyser IVD.

Cleared under the same submission

K223179 also covers:

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 7a315590-c94b-4a86-96bd-f7a889ce854e 37 fields · synced Jun 9, 2026