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U.S. Department of Health and Human Services

Product Classification
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Device kit, rna detection, human papillomavirus
Definition For the detection of human papillomavirus RNA to aid in assessing risk of cancer.
Physical State Device is supplied as an in vitro diagnositc kit containing various reagents, instructions for use and possibly instrumentation and software.
Technical Method Utilizes nucleic acid probes and/or primers along with other reagents to detect human papillomavirus RNA directly from human specimens
Target Area Currently, this type of device is only utilized on cervical specimens, but other specimen types are possible.
Review Panel Microbiology
Product CodeOYB
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Microbiology Devices (DMD)
Submission Type PMA
Device Class 3
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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