Home › Device types › OTR
Research Use Only/Immunology Devices
FDA product code OTR · Class N · Unknown
0
Registered devices
0
Adverse events
1
Recalls
0
510(k) clearances
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-11-03 | Diagnostic Hybrids, Inc. | A component of the kit was found to contain bacterial contamination. |
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