Assay, Nucleic Acid Amplification, Bacillus Anthracis

NHT · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3045

Classification

FDA Product Code: NHT
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 866.3045
Review panel: MI
Medical specialty: Microbiology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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 data

Cleared 510(k) submissions: 6
Registered establishments: 1

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown