PVQ · Class II · 21 CFR 866.3316

FDA Product Code PVQ: Rickettsia Spp. Nucleic Acid Based Detection Assay

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.

1
Total
1
Cleared
91d
Avg days
2017
Since

FDA 510(k) Cleared Rickettsia Spp. Nucleic Acid Based Detection Assay Devices (Product Code PVQ)

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About Product Code PVQ - Regulatory Context