LACTOFERRIN CHEK

GUDID 00857031002271

The LACTOFERRIN CHEK test is an ELISA 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 irritable bowel syndrome (IBS), which is noninflammatory.

TECHLAB, INC.

Lactoferrin IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00857031002271
NIH Device Record Key9d05776c-34fb-45a1-b079-36d80e1830d9
Commercial Distribution StatusIn Commercial Distribution
Brand NameLACTOFERRIN CHEK
Version Model NumberT5008
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
GS100857031002271 [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 Date2019-04-22
Device Publish Date2019-04-12

On-Brand Devices [LACTOFERRIN CHEK]

00857031002271The LACTOFERRIN CHEK test is an ELISA for the qualitative detection of elevated levels of lactof
00857031002080The LACTOFERRIN CHEK test is an ELISA for the qualitative detection of elevated levels of lactof

Trademark Results [LACTOFERRIN CHEK]

Mark Image

Registration | Serial
Company
Trademark
Application Date
LACTOFERRIN CHEK
LACTOFERRIN CHEK
86591151 4924589 Live/Registered
TechLab, Inc.
2015-04-08

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