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U.S. Department of Health and Human Services

Product Classification

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Device nucleic acid detection system for non-viral microorganism(s) causing sexually transmitted infections
Definition A device to detect nucleic acids from non-viral microorganism(s) causing sexually transmitted infections is an in vitro diagnostic device intended for the detection and identification of nucleic acids from non-viral microorganism(s) in clinical specimens collected from patients suspected of sexually transmitted infections. The device is intended to aid in the diagnosis of non-viral sexually transmitted infections in conjunction with other clinical and laboratory data.
Physical State In vitro diagnostic device consisting of reagents and associated instrumentation for the detection of nucleic acid sequences from Mycoplasma genitalium in clinical specimens.
Technical Method In vitro diagnostic device that detects and identifies nucleic acid sequences from Mycoplasma genitalium in clinical specimens.
Target Area Clinical specimens from patients suspected of Mycoplasma genitalium infection.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeQEP
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.3393
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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