OIH · Yersinia Spp. Reagents
· Class U
Overview
| Product Code | OIH |
|---|---|
| Device Name | Yersinia Spp. Reagents |
| Device Class | Class U |
| Review Panel |
Identification
Yersinia spp. reagents are devices that consist of Serological Reagents and Nucleic Acid Amplification Reagents to differentiate Yersinia spp. and presumptively identify Yersinia pestis (Y. pestis) from cultured isolates or clinical specimens. They are indicated for use as an aid in the laboratory of diagnosis of plague.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K131729 | JBAIDS PLAGUE DETECTION KIT | Biofire Diagnostics, Inc. | Jul 31, 2013 | SESE |
Top Applicants
- Biofire Diagnostics, Inc. — 1 clearance
