PMA P170022S005

Device: PyloPlus UBT System
Applicant: Arj Medical, Inc.
PMA number: P170022
Supplement: S005
Product code: OZA
Decision date: 2025-02-12
Classification: Microbiology
Generic name: Test, urea adult and pediatric (breath),
Approval order statement: Approval for the PyloPlus UBT system used with the PyloPlus UBT Hp Pro Analyzer with improved connectivity, user interface, and extended function testing as a standalone device without a PC.

Current openFDA PMA Record#

Device: PyloPlus UBT System
Applicant: Arj Medical, Inc.
PMA number: P170022
Supplement: S005
Product code: OZA
Generic name: Test, urea adult and pediatric (breath),
Decision date: 2025-02-12
Decision code: APPR
Date received: 2024-10-25
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the PyloPlus UBT system used with the PyloPlus UBT Hp Pro Analyzer with improved connectivity, user interface, and extended function testing as a standalone device without a PC.