OEH
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Joint Biological Agent Identification And Diagnostic System (Jbaids) Tularemia Detection Kit
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3280
- Medical specialty
- Microbiology
- 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| JBAIDS TULAREMIA DETECTION KIT (K131936) | Biofire Diagnostics, Inc. | 2013-07-31 |
| JBAIDS TULAREMIA DETECTION KIT, MODEL JRPD-ASY-0124 (K072547) | Idaho Technology, Inc. | 2007-12-19 |
Track OEH automatically
Every clearance here is in the API, with alerts when new ones post.