Who else makes this device?

Name: QuickVue TLI Lactoferrin Test
Brand: QuickVue TLI Lactoferrin Test

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

QuickVue TLI Lactoferrin Test

The QuickVue TLI Lactoferrin Test is an immunochromatographic test for the qualitative detection of elevated levels of lactoferrin, a marker for fecal leukocytes and an indicator of…

Registry build 21.09.26

The QuickVue TLI Lactoferrin 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).

1manufacturer

1catalogue number

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 QuickVue TLI Lactoferrin Test
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)	K030704
Record published	2019-05-30
Record revised	2022-06-10 (version 2)

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, manufacturing date

Catalogue Numbers

Catalogue numbers for QuickVue TLI Lactoferrin Test
Catalogue number	Size	Status
20345		In distribution

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
Leuko EZ VUE	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

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.