NHT
6 FDA 510(k) clearances · Product code
92 daysmedian time to decision
144 days90th percentile
6clearances measured
FDA profile
- Official device name
- Assay, Nucleic Acid Amplification, Bacillus Anthracis
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3045
- Medical specialty
- Microbiology
- FDA definition
- An invitro diagnostic device used to presumptively detect the presence or absence of b. Anthracis directly in blood specimens or suspicious culture growth.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| B. anthracis Real-time PCR Assay (K192871) | Centers for Disease Control and Prevention | 2019-11-07 |
| ANTHRACIS REAL-TIME PCR ASSAY (K140426) | Centers For Disease Control and Prevention (CDC) | 2014-05-22 |
| JBAIDS ANTHRAX DETECTION KIT (K131930) | Biofire Diagnostics, Inc. | 2013-08-05 |
| JBAIDS PLAQUE DETECTION KIT, MODEL JRPD-ASY-0123 (K072631) | Idaho Technology, Inc. | 2007-12-20 |
| MODIFICATION TO JBAIDS ANTHRAX DETECTION SYSTEM (K071188) | Idaho Technology, Inc. | 2007-05-21 |
| JBAIDS ANTHRAC DETECTION SYSTEM (K051713) | Idaho Technology, Inc. | 2005-11-18 |
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Every clearance here is in the API, with alerts when new ones post.