CAMPYLOBACTER CHEK

GUDID 00857031002462

The CAMPYLOBACTER CHEK™ test is an enzyme immunoassay for the qualitative detection of a Campylobacter-specific antigen in human fecal specimens. The CAMPYLOBACTER CHEK™ test is designed to detect C. jejuni and C. coli from patients with signs and symptoms of gastroenteritis. The test is intended for use with preserved fecal specimens in transport media and unpreserved fecal specimens. Test results should be considered in conjunction with clinical findings and patient history.

TECHLAB, INC.

Multiple Campylobacter species antigen IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00857031002462
NIH Device Record Key4474957a-ce0e-4197-ab0e-14dba31b6032
Commercial Distribution StatusIn Commercial Distribution
Brand NameCAMPYLOBACTER CHEK
Version Model NumberT5052
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
GS100857031002462 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LQPCampylobacter Spp.

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-06-06
Device Publish Date2019-05-29

On-Brand Devices [CAMPYLOBACTER CHEK]

00857031002462The CAMPYLOBACTER CHEK™ test is an enzyme immunoassay for the qualitative detection of a Campy
00857031002486The CAMPYLOBACTER CHEK™ test is an enzyme immunoassay for the qualitative detection of a Campy

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