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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device simple point-of-care nucleic acid-based hepatitis c virus ribonucleic acid test
Definition A simple point-of-care nucleic acid-based hepatitis C virus (HCV) ribonucleic acid (RNA) test is an in vitro diagnostic device that is intended for prescription use for the detection of HCV RNA in clinical specimens as an aid in the diagnosis of HCV infection or as an aid in the management of HCV-infected patients, including individuals without antibodies to HCV. This device is simple to use and does not involve sample manipulation, transportation of the sample to another functional area (e.g., a central laboratory or other specialized area), or measurement of reagents or analytes that could be affected by conditions such as sample turbidity or cell lysis. The test is not intended for use as a donor screening test for the presence of HCV RNA in blood, blood products, or tissue donors.
Product CodeSBP
Regulation Number 866.3171
Device Class 2


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ManufacturerDecision
CEPHEID
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