Assay, Nucleic Acid Amplification, Bacillus Anthracis
FDA product code NHT · Class II (moderate risk) · 21 CFR 866.3045 · Microbiology
An invitro diagnostic device used to presumptively detect the presence or absence of b. Anthracis directly in blood specimens or suspicious culture growth.
6510(k) clearances
0PMA approvals
1recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K192871 | B. anthracis Real-time PCR AssayNHT · Special | Centers for Disease Control and Prevention | 11/07/2019SE |
| K140426 | Anthracis Real-Time PCR AssayNHT · Traditional | Centers For Disease Control and Prevention (CDC) | 05/22/2014SE |
| K131930 | Jbaids Anthrax Detection KitNHT · Traditional | Biofire Diagnostics, Inc. | 08/05/2013SE |
| K072631 | Jbaids Plaque Detection Kit, Model JRPD-ASY-0123NHT · Traditional | Idaho Technology, Inc. | 12/20/2007SE |
| K071188 | Modification to Jbaids Anthrax Detection SystemNHT · Special | Idaho Technology, Inc. | 05/21/2007SE |
| K051713 | Jbaids Anthrac Detection SystemNHT · Traditional | Idaho Technology, Inc. | 11/18/2005SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2644-2014 Class III | JBAIDS Instrument System Software version 3.5.0.72. The JBAIDS instrument is a portable…BioFire Defense, LLC is initiating a field action for JBAIDS Software version 3.5.0.72 because the wrong… | Biofire Defense | 08/13/2014Terminated |