FDA product code OEH: Joint Biological Agent Identification And Diagnostic System (Jbaids) Tularemia Detection Kit
OEH is the FDA product code for joint biological agent identification and diagnostic system (jbaids) tularemia detection kit. It is a Class II device, regulated under 21 CFR 866.3280 and reviewed by the Microbiology panel. FDA has cleared 2 510(k) submissions under OEH, from 2 different applicants. The average 510(k) review took 67 days (median 67).
Definition
To aid in the diagnosis of individuals presenting with signs and symptoms of pneumonic or typhoidal tularemia with a qualitative in vitro diagnostic (ivd) detection of target dna sequences of francisella tularensis.
Classification
| Field | Value |
|---|---|
| Device name | Joint Biological Agent Identification And Diagnostic System (Jbaids) Tularemia Detection Kit |
| Device class | Class II |
| Regulation | 21 CFR 866.3280 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every OEH clearance
Top OEH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Biofire Diagnostics, Inc. | 1 | 2013-07-31 |
| Idaho Technology, Inc. | 1 | 2007-12-19 |
Most recent OEH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K131936 | Biofire Diagnostics, Inc. | JBAIDS TULAREMIA DETECTION KIT | 2013-07-31 | 34 |
| K072547 | Idaho Technology, Inc. | JBAIDS TULAREMIA DETECTION KIT, MODEL JRPD-ASY-0124 | 2007-12-19 | 100 |
Recalls for OEH devices
openFDA lists no recalls for product code OEH.
Frequently asked questions
What is FDA product code OEH?
OEH is the FDA product code for joint biological agent identification and diagnostic system (jbaids) tularemia detection kit. It is a Class II device, regulated under 21 CFR 866.3280 and reviewed by the Microbiology panel.
What device class is OEH?
Class II, regulation 21 CFR 866.3280. Typical premarket route: 510(k).
How long does a 510(k) take for product code OEH?
Across 2 cleared submissions the average was 67 days from receipt to decision (median 67).
Which companies have the most OEH clearances?
Biofire Diagnostics, Inc. (1); Idaho Technology, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OEH
- Run a recall and safety report across every OEH manufacturer
- Watch product code OEH 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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