H. PYLORI QUIK CHEK

GUDID 00857031002493

The TECHLAB® H. PYLORI QUIK CHEK™ test is a rapid membrane enzyme immunoassay for the qualitative detection of Helicobacter pylori specific antigen in a single use cassette. It is intended for use with human fecal specimens to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment. The test can be used with unpreserved fecal specimens and fecal specimens preserved in transport media from patients suspected of H. pylori infection. Testing of patients to demonstrate loss of H. pylori antigen following treatment should be performed no sooner than 4 weeks after completion of the treatment regimen. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms.

TECHLAB, INC.

Helicobacter pylori antigen IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00857031002493
NIH Device Record Keyb8e18c0a-cc78-400e-9561-f4463284ad9d
Commercial Distribution StatusIn Commercial Distribution
Brand NameH. PYLORI QUIK CHEK
Version Model NumberT5050
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
GS100857031002493 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LYRHelicobacter Pylori

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-29
Device Publish Date2018-09-28

On-Brand Devices [H. PYLORI QUIK CHEK]

00857031002516The TECHLAB® H. PYLORI QUIK CHEK™ test is a rapid membrane enzyme immunoassay for the qualita
00857031002493The TECHLAB® H. PYLORI QUIK CHEK™ test is a rapid membrane enzyme immunoassay for the qualita
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