H. PYLORI CHEK

GUDID 00857031002523

The TECHLAB® H. PYLORI CHEK™ test is an enzyme immunoassay for the qualitative detection of Helicobacter pylori specific antigen. 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.

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Primary Device ID	00857031002523
NIH Device Record Key	a40f669a-12cd-43fc-a91b-18dc3b646038
Commercial Distribution Status	In Commercial Distribution
Brand Name	H. PYLORI CHEK
Version Model Number	30996
Company DUNS	614218634
Company Name	TECHLAB, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857031002523 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K181400

FDA Product Code

LYR	Helicobacter Pylori

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2018-10-29
Device Publish Date	2018-09-28

On-Brand Devices [H. PYLORI CHEK]

00857031002523	The TECHLAB® H. PYLORI CHEK™ test is an enzyme immunoassay for the qualitative detection of H
00857031002509	The TECHLAB® H. PYLORI CHEK™ test is an enzyme immunoassay for the qualitative detection of H
00857031002639	The TECHLAB® H. PYLORI CHEK™ test is an enzyme immunoassay for the qualitative detection of H