Chlamydophila Pneumoniae Dna Assay System
Microbiology · 21 CFR 866.3980
A qualitative in vitro diagnostic assay intended to detect Chlamydophila pneumoniae DNA extracted from human respiratory specimens. Detection of Chlamydophila pneumoniae DNA aids in the diagnosis of Chlamydophila pneumoniae respiratory infection in conjunction with other clinical and laboratory testing in patients exhibiting signs and symptoms of upper respiratory tract infection.
Recent MDR events
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Registered firms
8 firms currently registered for this product code
Applied Biocode, Inc.
Santa Fe Springs, CA, 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
Luminex Corporation
Northbrook, IL, US
Biofire Diagnostics, Llc
Salt Lake City, UT, US
Biofire Defense, Llc
Salt Lake City, UT, US
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