Assay, genotyping, hepatitis c virus

Assay, genotyping, hepatitis c virus is the device name listed in this FDA PMA record. The listed applicant is Fujirebio Europe N.V.. It received FDA Premarket Approval (PMA) on 2020-09-23 under PMA number P160016. The device is classified under FDA product code OBF. It was reviewed by the MI advisory panel. This device is classified as Class II by the FDA. Class III devices subject to special controls, in addition to general controls. These devices typically require premarket notification (510(k)). PMA is the most stringent type of device marketing application required by the FDA. The device falls under the medical specialty of M. It is regulated under 21 CFR Part 8. Unlike 510(k) clearance, which demonstrates substantial equivalence to a predicate device, PMA requires valid scientific evidence providing reasonable assurance of safety and effectiveness. PMA is generally required for Class III devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury.