Influenza A Virus Subtype Differentiation Nucleic Acid Assay
Microbiology · 21 CFR 866.3980
A qualitative in vitro diagnostic assay intended to detect and differentiate between influenza a virus subtypes in human respiratory specimens or viral culture. Detection and differentiation of specific subtype rna aids in the diagnosis of influenza caused by influenza a in conjunction with other clinical and laboratory testing in patients suspected of being infected with these viruses. Also, it aids in the presumptive laboratory identification of influenza a virus subtypes to provide epidemiological information on influenza.
Recent MDR events
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Event type breakdown
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Most-reported manufacturers
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Recalls
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Registered firms
11 firms currently registered for this product code
Applied Biocode, Inc.
Santa Fe Springs, CA, US
Acro Biotech Inc.
Montclair, 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
Hochuen Medical Technology Co.,ltd.
Shenzhen Guangdong, CN
Luminex Molecular Diagnostics, Inc.
TORONTO Ontario, CA
Diamond Diagnostics Inc.
Budapest, HU
Luminex Corporation
Northbrook, IL, US
Biofire Diagnostics, Llc
Salt Lake City, UT, US
510(k) clearances
1 clearances for this product code