H. PYLORI CHEK

GUDID 00857031002639

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.

Helicobacter pylori antigen IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00857031002639
• NIH Device Record Key: c1ac824d-0fac-4402-b7ce-7402e95eb61a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: H. PYLORI CHEK
• Version Model Number: T5051B
• 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	00857031002639 [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: 2021-03-22
• Device Publish Date: 2021-03-12

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