FDA Device Intelligence
Home › Device types › OZA

Test, Urea Adult And Pediatric (Breath),

FDA product code OZA · Class 3 · Microbiology

10
Registered devices
6
Adverse events
0
Recalls
0
510(k) clearances

Devices with this code

PyloPlus+ Urea Breath Test Analyzer — Arj Medical, Inc.BreathTek UBT for H. pylori — MERIDIAN BIOSCIENCE, INC.PyloPlus+ Urea Breath Test Pro Analyzer — Arj Medical, Inc.Pediatric Urea Hydrolysis Rate Calculation Application pUHR-CA — MERIDIAN BIOSCIENCE, INC.Pediatric Urea Hydrolysis Rate Calculation Application pUHR-CA — Otsuka America Pharmaceutical IncBreathTek® UBT for H. pylori Kit (BreathTek UBT Kit) — Otsuka America Pharmaceutical IncPyloPlus+ Urea Breath Test Kit — Arj Medical, Inc.PyloPlus+ Urea Breath Test Lab Analyzer — Arj Medical, Inc.BreathTek® UBT for H. pylori Kit (Metabolic Solutions Kit) — Otsuka America Pharmaceutical IncPediatric Urea Hydrolysis Rate Calculation Application pUHR-CA — Otsuka America Pharmaceutical Inc

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.