PMA P170022S003

Device: PyloPlus® UBT System
Applicant: Arj Medical, Inc.
PMA number: P170022
Supplement: S003
Product code: OZA
Decision date: 2024-01-11
Classification: Microbiology
Generic name: Test, urea adult and pediatric (breath),
Approval order statement: Approval of the PyloPlus® UBT System.The PyloPlus UBT system is intended for use in the qualitative detection of urease associated with H. pylori in the human stomach and is indicated as an aid in the initial diagnosis and post treatment monitoring of H. pylori infection in adults and pediatric patients ages 3-17 years old. The PyloPlus UBT system consists of the PyloPlus UBT Kit and the PyloPlus UBT analyzer. The analyzer is an infrared Spectrometer used for the measurement of the ratio of 13CO2 to 12CO2 in breath samples. The PyloPlus UBT system is for use by trained health care professionals as prescribed by a physician.

Current openFDA PMA Record#

Device: PyloPlus® UBT System
Applicant: Arj Medical, Inc.
PMA number: P170022
Supplement: S003
Product code: OZA
Generic name: Test, urea adult and pediatric (breath),
Decision date: 2024-01-11
Decision code: APPR
Date received: 2023-05-23
Supplement type: Panel Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval of the PyloPlus® UBT System.The PyloPlus UBT system is intended for use in the qualitative detection of urease associated with H. pylori in the human stomach and is indicated as an aid in the initial diagnosis and post treatment monitoring of H. pylori infection in adults and pediatric patients ages 3-17 years old. The PyloPlus UBT system consists of the PyloPlus UBT Kit and the PyloPlus UBT analyzer. The analyzer is an infrared Spectrometer used for the measurement of the ratio of 13CO2 to 12CO2 in breath samples. The PyloPlus UBT system is for use by trained health care professionals as prescribed by a physician.