Test, Urea Adult And Pediatric (breath),
Device Code: 3546
Product Code(s):
OZA Definition: 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. The Test
Device Classification Information
| Device Type ID | 3546 |
| Device Name | Test, Urea Adult And Pediatric (breath), |
| Physical State | Human Breath |
| Technical Method | System Utilizes An Infrared Spectrophotometer |
| Target Area | Stomach, Esophagogastroduodenoscopy |
| Regulation Description | Campylobacter Fetus Serological Reagents. |
| Regulation Medical Specialty | Microbiology |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | PMA |
| CFR Regulation Number | 866.3110 [🔎] |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | OZA |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 3546 |
| Device | Test, Urea Adult And Pediatric (breath), |
| Product Code | OZA |
| FDA Device Classification | Class 3 Medical Device |
| Regulation Description | Campylobacter Fetus Serological Reagents. |
| CFR Regulation Number | 866.3110 [🔎] |
TPLC Last Update: 2019-04-02 20:32:08