Prospective Transfer of Ownership and Exclusive Use of 510(K) Number K113336 for the CDC DENV-1-4 Real-Time RT-PCR ASSAY

摘要

This is notice that the Centers for Disease Control and Prevention, Department of Health and Human Services, is contemplating the transfer of ownership and exclusive use of 510(k) Number K113336 to American Type Culture Collection (ATCC), a District of Columbia non- profit corporation. 510(k) Number K113336 allows marketing of the CDC DENV-1-4 Real-Time RT-PCR Assay, an in vitro molecular diagnostic test that consists of a panel of oligonucleotide primers and dual-labeled hydrolysis (TaqMan[supreg]) probes for the qualitative detection of dengue virus target sequences in serum and plasma using nucleic acid isolation, amplification, and detection on the ABI 7500 Fast Dx Real- Time PCR instrument. The contemplated transfer would occur in conjunction with the grant of a non-exclusive patent license to ATCC to practice the inventions embodied in patent applications under HHS Ref. No E-148-2013/0, including U.S. Provisional Patent Application No. 61/ 554,126, entitled "Broad Detection of Dengue Virus Serotypes", filed November 1, 2011.