PMA P170022S007

Device: PyloPlus UBT System
Applicant: Arj Medical, Inc.
PMA number: P170022
Supplement: S007
Product code: OZA
Decision date: 2026-02-05
Classification: Microbiology
Generic name: Test, urea adult and pediatric (breath),
Approval order statement: Approval to add the PyloPlus UBT Auto Sampler used with glass breath collection tubes for use with the PyloPlus UBT System using the PyloPlus UBT Lab Analyzer (PPUBTLA -04), and for additions to test kit packaging.

Current openFDA PMA Record#

Device: PyloPlus UBT System
Applicant: Arj Medical, Inc.
PMA number: P170022
Supplement: S007
Product code: OZA
Generic name: Test, urea adult and pediatric (breath),
Decision date: 2026-02-05
Decision code: APPR
Date received: 2025-08-05
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval to add the PyloPlus UBT Auto Sampler used with glass breath collection tubes for use with the PyloPlus UBT System using the PyloPlus UBT Lab Analyzer (PPUBTLA -04), and for additions to test kit packaging.