FDA Device Intelligence
Home › Otsuka America Pharmaceutical Inc › BreathTek® UBT for H. pylori Kit (Metabolic Solutions Kit)

BreathTek® UBT for H. pylori Kit (Metabolic Solutions Kit)

Otsuka America Pharmaceutical Inc · Model 01M · UDI-DI 00857335005039

OZA Prescription
0
510(k) clearances
6
Adverse events
0
Recalls
2
Facilities

Description

This is the Metabolic Solutions Kit version of the kit.

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
Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.