Leuko Ez Vue

FDA UDI

Class I (US FDA UDI)

by Techlab, Inc.

Identity

Trade Name: LEUKO EZ VUE FDA UDI
Generic Name: Lactoferrin IVD, kit, rapid ICT, clinical FDA UDI
Device Name: The LEUKO EZ VUE® test is an immunochromatographic test for the qualitative detection of elevated levels of fecal lactoferrin, a marker for fecal leukocytes and an indicator of intestinal inflammation. The LEUKO EZ VUE® test detects lactoferrin in liquid, semi-solid, and solid fecal specimens. A positive test result indicates an increased level of fecal lactoferrin and warrants additional testing. FDA UDI
Model / Reference: T30355 FDA UDI
Description: The LEUKO EZ VUE® test is an immunochromatographic test for the qualitative detection of elevated levels of fecal lactoferrin, a marker for fecal leukocytes and an indicator of intestinal inflammation. The LEUKO EZ VUE® test detects lactoferrin in liquid, semi-solid, and solid fecal specimens. A positive test result indicates an increased level of fecal lactoferrin and warrants additional testing. FDA UDI

Identifiers

Primary DI / UDI-DI: 00857031002172 FDA UDI
510(k) Number: K071712 FDA UDI
FDA Product Code: DEG FDA UDI
GMDN Term: Lactoferrin IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 866.5570 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Lactoferrin IVD, kit, rapid ICT, clinical

Leuko Ez Vue by Techlab, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Lactoferrin IVD, kit, rapid ICT, clinical.

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LACTOFERRIN EZ VUE — TECHLAB, INC. · Class I
LACTOFERRIN EZ VUE — TECHLAB, INC. · Class I
QuickVue TLI Lactoferrin Test — TECHLAB, INC. · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Techlab, Inc.

Sources (1)

FDA UDI e93109c8-ec96-42cd-adfe-8e4ef92eaf94 34 fields · synced Jun 1, 2026