FDA product code OIH: Yersinia Spp. Reagents
OIH is the FDA product code for yersinia spp. reagents. It is a Unclassified device, reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under OIH. The average 510(k) review took 49 days (median 49).
Definition
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.
Classification
| Field | Value |
|---|---|
| Device name | Yersinia Spp. Reagents |
| Device class | Unclassified |
| Review panel | MI — Microbiology |
| Medical specialty | Unknown |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every OIH clearance
Top OIH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Biofire Diagnostics, Inc. | 1 | 2013-07-31 |
Most recent OIH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K131729 | Biofire Diagnostics, Inc. | JBAIDS PLAGUE DETECTION KIT | 2013-07-31 | 49 |
Recalls for OIH devices
openFDA lists no recalls for product code OIH.
Frequently asked questions
What is FDA product code OIH?
OIH is the FDA product code for yersinia spp. reagents. It is a Unclassified device, reviewed by the Microbiology panel.
What device class is OIH?
Unclassified. Typical premarket route: 510(k).
How long does a 510(k) take for product code OIH?
Across 1 cleared submissions the average was 49 days from receipt to decision (median 49).
Which companies have the most OIH clearances?
Biofire Diagnostics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OIH
- Run a recall and safety report across every OIH manufacturer
- Watch product code OIH for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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