FDA product code · Microbiology
Chlamydophila Pneumoniae Dna Assay System
0 FDA decisions. No recall names this code.
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.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
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Other codes under 21 CFR 866.3980.