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Multi-Analyte Respiratory Virus Antigen Detection Test

Multi-Analyte Respiratory Virus Antigen Detection Test 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.

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Multi-Analyte Respiratory Virus Antigen Detection Test
Microbiology Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

SCA

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Class 2

21 CFR 866.3987

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Microbiology

Device Characteristics

No

No

No

Not Eligible

Definition

A multi-analyte respiratory virus antigen detection test is an in vitro diagnostic device intended for the detection and/or differentiation of respiratory viruses directly from respiratory clinical specimens. The device is intended to be performed at the site of sample collection, does not involve sample storage and/or transport.