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Leader

FDA UDI

Class II (US FDA UDI)

by Cardinal Health 110, Inc.

Identity

Trade Name
LEADER FDA UDI
Generic Name
Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
Device Name
LDR At-Home Drug Test (12 drugs tested) FDA UDI
Model / Reference
5688338 FDA UDI
Description
LDR At-Home Drug Test (12 drugs tested) FDA UDI

Identifiers

Catalog Number
5688338 FDA UDI
Primary DI / UDI-DI
00096295140583 FDA UDI
FDA Product Code
DIJ FDA UDI
DIT FDA UDI
LAB FDA UDI
DOM FDA UDI
LCM FDA UDI
DNK FDA UDI
DKX FDA UDI
DKZ FDA UDI
LDJ FDA UDI
DJC FDA UDI
MLK FDA UDI
GMDN Term
Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.3550 FDA UDI
862.3100 FDA UDI
862.3170 FDA UDI
862.3250 FDA UDI
862.3640 FDA UDI
862.3150 FDA UDI
862.3870 FDA UDI
862.3610 FDA UDI
862.3910 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

No

FDA UDI

Over-the-Counter

Yes

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

No

FDA UDI

Category: Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Leader by Cardinal Health 110, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple drugs of abuse IVD, kit, rapid ICT, clinical.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cardinal Health 110, Inc.

Sources (1)

  • FDA UDI 2dbe321b-a129-49d9-b0d1-5b852500d490 36 fields · synced Jun 8, 2026