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Test, Urea (Breath Or Blood)
FDA product code MSQ · Class 1 · Microbiology
11
Registered devices
24
Adverse events
2
Recalls
17
510(k) clearances
Devices with this code
BreathID Hp Lab Device — MERIDIAN BIOSCIENCE ISRAEL LTDAuto Sampler (for BreathID Hp Lab System) — MERIDIAN BIOSCIENCE ISRAEL LTDBreathID Hp System — MERIDIAN BIOSCIENCE ISRAEL LTDBreathID Hp Lab System refurbished — MERIDIAN BIOSCIENCE ISRAEL LTDBreathID Smart System — MERIDIAN BIOSCIENCE ISRAEL LTDBreathID Hp System — MERIDIAN BIOSCIENCE ISRAEL LTDBreathID Hp Lab System — MERIDIAN BIOSCIENCE ISRAEL LTDBreathID Hp Lab Device (WIN) — MERIDIAN BIOSCIENCE ISRAEL LTDBreathID Smart System refurbished — MERIDIAN BIOSCIENCE ISRAEL LTDBreathID Smart System — MERIDIAN BIOSCIENCE ISRAEL LTDBreathID Smart System — MERIDIAN BIOSCIENCE ISRAEL LTD
Recent 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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