PRA · Class II · 21 CFR 866.3316

FDA Product Code PRA: Variola Virus Nucleic Acid-based Detection Assay

The Variola Virus Nucleic Acid-based Detection Assay Is Intended For Individuals Presenting With Pustular Or Vesicular Rash Illness Or Other Signs And Symptoms Of Variola Virus Infection. The Test Results Must Be Used In Conjunction With Other Diagnostic Assays And Clinical Observations, As An Aid To The Diagnosis Of Infection, In Accordance With The Criteria Defined By The Appropriate Public Health Authorities With The Federal Government.

1
Total
0
Cleared
298d
Avg days
2017
Since

FDA 510(k) Cleared Variola Virus Nucleic Acid-based Detection Assay Devices (Product Code PRA)

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About Product Code PRA - Regulatory Context