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Leader

FDA UDI

Class I (US FDA UDI)

by Cardinal Health 110, Inc.

Identity

Trade Name
LEADER FDA UDI
Generic Name
Urine nitrite IVD, kit, rapid colorimetric, clinical FDA UDI
Device Name
Leader Urinary Tract Infection Home Test, 3 COUNT FDA UDI
Model / Reference
5465349 FDA UDI
Description
Leader Urinary Tract Infection Home Test, 3 COUNT FDA UDI

Identifiers

Catalog Number
5465349 FDA UDI
Primary DI / UDI-DI
00096295135855 FDA UDI
FDA Product Code
JMT FDA UDI
LJX FDA UDI
GMDN Term
Urine nitrite IVD, kit, rapid colorimetric, clinical FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1510 FDA UDI
864.7675 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: Urine nitrite IVD, kit, rapid colorimetric, clinical

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

Similar devices

Also classified as Urine nitrite IVD, kit, rapid colorimetric, 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 474961e6-838d-4af0-b344-9d565ccbbb6e 36 fields · synced May 30, 2026