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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device assay, direct, nucleic acid amplification, q fever
Regulation Description Rickettsia serological reagents.
Definition These reagents are nucleic acid primers and probes intended for the amplification and identification of Coxiella burnetii directly from clinical specimens. The identification aids in the diagnosis of Q Fever and provides epidemiological information on this disease. This reagent differs from the description in the regulation in that it consists of nucleic acid primers and probes rather than antisera or antigens.
Product CodeOVF
Regulation Number 866.3500
Device Class 1

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