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BreathID Hp System
MERIDIAN BIOSCIENCE ISRAEL LTD · Model VS01000R · UDI-DI 07290016923148
2
510(k) clearances
24
Adverse events
2
Recalls
1
Facilities
Description
The BreathID® Hp System is intended for use to continually and non-invasively measure changes in the13CO2 /12CO2 ratio of exhaled breath, which may be indicative of increased urease production associated with active Helicobacter pylori (H. pylori) infection in the stomach. The BreathID® Hp System is indicated for use as an aid in the initial diagnosis and post treatment monitoring of H. pylori infection in adult patients and pediatric patients ages 3-17 years old. The BreathID® Hp System consists of the appropriate IDkit:Hp™ kit and the BreathID® Hp test device.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2011-06-07 | Exalenz Bioscience Ltd | The product is in violation of the FD&C Act in that it was illegally marketed without proper clearance (no 510(k) submitted). |
| 2007-05-02 | Meretek Diagnostics, Inc. | Diagnostic test kit for Helicobacter pylori was distributed for adult and pediatric use, but was not approved for pediatric use. |
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Get your free API keyRead the docsData 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.