Who else makes this device?

Name: Leuko EZ VUE
Brand: Leuko EZ VUE

Immunology & Microbiology › Immunological Test SystemsLactoferrin, Antigen, Antiserum, Control

Leuko EZ VUE

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…

Registry build 21.09.26

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.

1manufacturer

2catalogue numbers in this listing

4510(k) clearances naming this product code

Who Else Makes It

Registered in Hunan.

Chinese manufacturers registered for FDA product code DEG
Manufacturer	City	Province	Registered as	Device types
AVE Science & Technology Co., Ltd.	Changsha	Hunan	Manufacturer	22

Record

Regulatory record for Leuko EZ VUE
Listed by	Techlab, Inc., United States
FDA product code	DEG
Device type	Lactoferrin, Antigen, Antiserum, Control
Device class	Class 1
Regulation	21 CFR 866.5570
Establishment	Manufacturer
510(k)	K071712
Record published	2020-01-24
Record revised	2023-08-15 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date
Distribution end date	2021-07-19

Catalogue Numbers

Catalogue numbers for Leuko EZ VUE
Catalogue number	Size	Status
T30355		In distribution
T5019		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Anti-Lactoferrin Elisa	DRG Instruments Gesellschaft mit beschränkter Haftung	2
Lactoferrin Chek	Techlab, Inc.	2
Lactoferrin EZ VUE	Techlab, Inc.	2
Lactoferrin Scan	Techlab, Inc.	2
Lactoferrin Elisa	Immundiagnostik, Inc.	2
Alpco Lactoferrin Clia Kit	American Laboratory Products Company	2
Lactoferrin Clia Re-Calibrator and Control Set	American Laboratory Products Company	1
GeroaDX	Geroa Diagnostics Sociedad Limitada	1
QuickVue TLI Lactoferrin Test	Techlab, Inc.	1

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K042071	2004-10-20
K030704	2003-04-21
K011396	2001-06-18
K951101	1995-04-24

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.