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  • Molecular diagnostic laboratory analyzers designed to use nucleic acid diagnostic techniques to identify and/or quantify specific molecules belonging or related to microorganisms (e.g., bacteria, viruses, fungi) that infect humans. These analyzers perform appropriate sequential cycles of incubation, replication (amplification), washing, and detection; some include a thermal cycle (e.g., polymerase chain reaction), but others use an isothermal process. Infectious disease molecular diagnostic laboratory analyzers are used in the detection of bacteria (e.g., Chlamydia trachomatis, Neisseria gonorrhoeae), mycobacteria (e.g., Mycobacterium tuberculosis), and viruses (e.g., human immunodeficiency, hepatitis C).
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