Lactoferrin Ez Vue

FDA UDI

Class I (US FDA UDI)

by Techlab, Inc.

Identity

Trade Name: LACTOFERRIN EZ VUE FDA UDI
Generic Name: Lactoferrin IVD, kit, rapid ICT, clinical FDA UDI
Device Name: The LACTOFERRIN EZ VUE® test is an immunochromatographic test for the qualitative detection of elevated levels of lactoferrin, a marker for fecal leukocytes and an indicator of intestinal inflammation. The test can be used as an in vitro diagnostic aid to help identify patients with active inflammatory bowel disease (IBD) and rule out those with active noninflammatory irritable bowel syndrome (IBS). FDA UDI
Model / Reference: T5018 FDA UDI
Description: The LACTOFERRIN EZ VUE® test is an immunochromatographic test for the qualitative detection of elevated levels of lactoferrin, a marker for fecal leukocytes and an indicator of intestinal inflammation. The test can be used as an in vitro diagnostic aid to help identify patients with active inflammatory bowel disease (IBD) and rule out those with active noninflammatory irritable bowel syndrome (IBS). FDA UDI

Identifiers

Primary DI / UDI-DI: 00857031002356 FDA UDI
510(k) Number: K030704 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

Lactoferrin 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.

Axim Biotechnologies T-POC Lactoferrin Immunoassay Kit — Axim Biotechnologies, Inc.
LACTOFERRIN EZ VUE — TECHLAB, INC. · Class I
LEUKO EZ VUE — TECHLAB, INC. · Class I
QuickVue TLI Lactoferrin Test — TECHLAB, INC. · Class I

Cleared under the same submission

K030704 also covers:

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 087767f9-31ae-4d8b-a936-eae8fa744d50 34 fields · synced Jun 8, 2026