NHT — Assay, Nucleic Acid Amplification, Bacillus Anthracis Class II
Classification Details
- Product Code
- NHT
- Device Class
- Class II
- Regulation Number
- 866.3045
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Definition
An invitro diagnostic device used to presumptively detect the presence or absence of b. Anthracis directly in blood specimens or suspicious culture growth.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K192871 | centers for disease control and prevention | B. anthracis Real-time PCR Assay | November 7, 2019 |
| K140426 | centers for disease control and prevention (cdc) | ANTHRACIS REAL-TIME PCR ASSAY | May 22, 2014 |
| K131930 | biofire diagnostics | JBAIDS ANTHRAX DETECTION KIT | August 5, 2013 |
| K072631 | idaho technology | JBAIDS PLAQUE DETECTION KIT, MODEL JRPD-ASY-0123 | December 20, 2007 |
| K071188 | idaho technology | MODIFICATION TO JBAIDS ANTHRAX DETECTION SYSTEM | May 21, 2007 |
| K051713 | idaho technology | JBAIDS ANTHRAC DETECTION SYSTEM | November 18, 2005 |