Pure Global

System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen

System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen 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
System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen
Microbiology Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

POC

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Class 2

21 CFR 866.1640

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Microbiology

Device Characteristics

No

No

No

Not Eligible

Definition

To detect the presence of genetic markers of antimicrobial resistance by testing directly from clinical specimens using nucleic acid amplification technology.