Parainfluenza Multiplex Nucleic Acid Assay
Microbiology · 21 CFR 866.3980
A parainfluenza multiplex nucleic acid assay is a multiplex in vitro diagnostic test for the simultaneous qualitative detection and discrimination of parainfluenza 1 virus, parainfluenza 2 virus, parainfluenza 3 virus and parainfluenza 4 virus nucleic acids isolated and purified from human respiratory specimens obtained from individuals exhibiting signs and symptoms of respiratory tract infections or viral culture. The detection and discrimination of human parainfluenza nucleic acids from symptomatic patients aid in the diagnosis of human respiratory tract parainfluenza infections if used in conjunction with other clinical and laboratory findings.
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
15 firms currently registered for this product code
Applied Biocode, Inc.
Santa Fe Springs, CA, US
Diamond Diagnostics Inc
Holliston, MA, US
Luminex Corporation
AUSTIN, TX, US
Genmark Diagnostics, Inc.
Carlsbad, CA, US
Hochuen Medical Sdn. Bhd.
SENAI Johor, MY
Hologic, Inc.
SAN DIEGO, CA, US
Hochuen Medical Technology Co.,ltd.
Shenzhen Guangdong, CN
Luminex Molecular Diagnostics, Inc.
TORONTO Ontario, CA
Diamond Diagnostics Inc.
Budapest, HU
Ortho-clinical Diagnostics, Inc.
ATHENS, OH, US
Luminex Corporation
Northbrook, IL, US
Biofire Diagnostics, Llc
Salt Lake City, UT, US
Biofire Defense, Llc
Salt Lake City, UT, US
510(k) clearances
5 clearances for this product code