Pure Global

Assay, Direct, Nucleic Acid Amplification, Parainfluenza Virus

Assay, Direct, Nucleic Acid Amplification, Parainfluenza Virus 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, Direct, Nucleic Acid Amplification, Parainfluenza Virus
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

NHZ

View Product Code Classification

Class 1

21 CFR 866.3400

View CFR Regulation

Microbiology

Device Characteristics

No

No

No

Eligible

Definition

These reagents are nucleic acid primers and probes for the amplification and identification of Parainfluenza virus directly from clinical specimens. The identification aids in the diagnosis of influenza and provides epidemiological information on this disease. This reagent differs from the description in the regulation in that it consists of nucleic acid primers and probes rather than antisera.