Pure Global

Assay, Nucleic Acid Amplification, Bacillus Anthracis

Assay, Nucleic Acid Amplification, Bacillus Anthracis is a medical device type in the Microbiology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.

Global Registration Data
Multi-Country Intelligence
Assay, Nucleic Acid Amplification, Bacillus Anthracis
Microbiology Medical Device Type
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Regulatory Classifications

US Regulatory Classifications

NHT

View Product Code Classification

Class 2

21 CFR 866.3045

View CFR Regulation

Microbiology

Device Characteristics

No

No

No

Not Eligible

Definition

An invitro diagnostic device used to presumptively detect the presence or absence of b. Anthracis directly in blood specimens or suspicious culture growth.

Search Keywords

Click to search for similar devices in our global database