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U.S. Department of Health and Human Services

Product Classification

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Device vaginitis and bacterial vaginosis nucleic acid detection system
Definition A vaginitis and bacterial vaginosis nucleic acid detection system is a qualitative in vitro diagnostic device for the direct detection of nucleic acid sequences from microorganisms associated with vaginitis or bacterial vaginosis.The device is indicated for individuals with signs and symptoms of vaginitis or bacterial vaginosis and aids in the diagnosis of these vaginal infections.
Physical State In vitro device consisting of reagents and associated instrumentation for detection of nucleic acid sequences from microorganisms associated with vaginitis or bacterial vaginosis.
Technical Method Qualitative in vitro diagnostic device that detects nucleic acid sequences from microorganisms associated with vaginitis or bacterial vaginosis.
Target Area In vitro diagnostic device
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodePQA
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.3975
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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