NHT

Assay, Nucleic Acid Amplification, Bacillus Anthracis

Product code

NHT

Device name

Assay, Nucleic Acid Amplification, Bacillus Anthracis

Device class

Class 2

21 CFR

21 CFR 866.3045

Medical specialty

Microbiology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

6 (all years; only the last 3 years are listed here)

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).