Approval of the pyloplus ubt. 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 of h. Pylori infection in adults 18 years old and older. 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.
| Device | PyloPlus UBT System |
| Generic Name | Test, Urea Adult And Pediatric (breath), |
| Applicant | ARJ Medical Inc. |
| Date Received | 2017-07-26 |
| Decision Date | 2020-02-18 |
| PMA | P170022 |
| Supplement | S |
| Product Code | OZA |
| Advisory Committee | Microbiology |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | ARJ Medical Inc. 209 State Street E oldsmar, FL 34677 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P170022 | Original Filing | |
| S001 | 2022-05-04 | Real-time Process |