LACTOFERRIN EZ VUE

GUDID 00857031002356

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).

TECHLAB, INC.

Lactoferrin IVD, kit, immunochromatographic test (ICT)
Primary Device ID00857031002356
NIH Device Record Key087767f9-31ae-4d8b-a936-eae8fa744d50
Commercial Distribution StatusIn Commercial Distribution
Brand NameLACTOFERRIN EZ VUE
Version Model NumberT5018
Company DUNS614218634
Company NameTECHLAB, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100857031002356 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DEGLactoferrin, Antigen, Antiserum, Control

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-06-10
Device Publish Date2019-05-31

On-Brand Devices [LACTOFERRIN EZ VUE]

00857031002189The LACTOFERRIN EZ VUE® test is an immunochromatographic test for the qualitative detection of
00857031002356The LACTOFERRIN EZ VUE® test is an immunochromatographic test for the qualitative detection of

Trademark Results [LACTOFERRIN EZ VUE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
LACTOFERRIN EZ VUE
LACTOFERRIN EZ VUE
86591195 5008955 Live/Registered
TechLab, Inc.
2015-04-08

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