Device |
assay, direct, nucleic acid amplification, q fever |
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 Code | OVF |
Regulation Number |
866.3500
|
Device Class |
1
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