510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
NHTClass II

Assay, Nucleic Acid Amplification, Bacillus Anthracis

21 CFR 866.3045 / Microbiology
FDA source (opens on fda.gov)

NHT is the FDA product code for Assay, Nucleic Acid Amplification, Bacillus Anthracis, a class II device type, regulated under 21 CFR 866.3045. FDA's definition for this code reads: "An invitro diagnostic device used to presumptively detect the presence or absence of b. Anthracis directly in blood specimens or suspicious culture growth". As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
NHT
Device name
Assay, Nucleic Acid Amplification, Bacillus Anthracis
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.
Regulation
21 CFR 866.3045
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
6
Ingested recalls
1

Clearances, product code NHT

By decision year
6 clearances under product code NHT with a decision year between 2005 and 2019, 2007 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code NHT by decision year
YearClearances
20051
20072
20131
20141
20191

Applicants with the most clearances

Product code NHT
Applicants holding the most 510(k) clearances under product code NHT
ApplicantClearances
Idaho Technology, Inc.3
BioFire Diagnostics, LLC1
Centers for Disease Control and Prevention (CDC)1
Centers for Disease Control and Prevention1

Companies listing this code with FDA

Companies whose registered establishments list this code