Product code NHT— Microbiology
B. anthracis Real-time PCR Assay
- Classification name
- Assay, Nucleic Acid Amplification, Bacillus Anthracis
- Device class
- Class 2
- Regulation
- 21 CFR 866.3045
- Advisory panel
- Microbiology
- Total cleared
- 7
- First cleared
- Most recent
FDA classification definition
“An invitro diagnostic device used to presumptively detect the presence or absence of b. Anthracis directly in blood specimens or suspicious culture growth.”
Market context for product code NHT
FDA has cleared devices under product code NHT between 2005 and 2026, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2026
- 2019
- 2014
- 2013
- 2007
- 2005
Top applicants under product code NHT
Recent clearances under product code NHT
- K262368 — B. anthracis Real-time PCR Assay
- K192871 — B. anthracis Real-time PCR Assay
- K140426 — ANTHRACIS REAL-TIME PCR ASSAY
- K131930 — JBAIDS ANTHRAX DETECTION KIT
- K072631 — JBAIDS PLAQUE DETECTION KIT, MODEL JRPD-ASY-0123
- K071188 — MODIFICATION TO JBAIDS ANTHRAX DETECTION SYSTEM
- K051713 — JBAIDS ANTHRAC DETECTION SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.