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, a class II device type, regulated under 21 CFR 866.3280. FDA's definition for this code reads: "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". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- OEH
- Device name
- Joint Biological Agent Identification And Diagnostic System (Jbaids) Tularemia Detection Kit
- FDA 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.
- Regulation
- 21 CFR 866.3280
- Device class
- Class II
- Review panel
- Microbiology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 2
- Ingested recalls
- 0
Clearances, product code OEH
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2007 | 1 |
| 2013 | 1 |
Applicants with the most clearances
Product code OEH| Applicant | Clearances |
|---|---|
| BioFire Diagnostics, LLC | 1 |
| Idaho Technology, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code OEH.
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