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Rickettsia Spp. Nucleic Acid Based Detection Assay

FDA product code PVQ · 1 cleared devices

Class 2 Microbiology
Regulation
21 CFR 866.3316
Review panel
MI
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2017-06-29 – 2017-06-29

An in vitro diagnostic test for the detection of Rickettsia spp. nucleic acids in specimens from individuals with signs or symptoms of rickettsial infection and epidemiological risk factors consistent with potential exposure. Test results are used in conjunction with other diagnostic assays and clinical observations to aid in the diagnosis infection, in accordance with criteria defined by the appropriate public health authorities in the Federal government.

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