definiens: means any process, method, test, kit, reagent and/or group of reagents for performing or, by virtue of its design, operation an d / or construction, has no other substantial practical utility than for performing, one or more of the following operations in connection with the practice of PCR : ( a ) Sample collection, preparation, transport and/or isolation of nucleic acid se quences from a sample, that is, the treatment of a sample in order to render a nucleic acid therein amplifiable and/or detectable, which may have as its essential active reagents, for example, the cell lysing, stabilization and/or precipitation reagents es sential to expose and prepare DNA for amplification and/or detection ; and/or ( b ) The amplification of one or more designated nucleic acid sequences using PCR, which may have as its essential active reagents, for example, the oligonucleotides an d / or nucleotides, enzymes, buffers and associated co -reactants essential to perform amplification of nucleic acid using PCR ; and/or 4 ( c ) Detection, that is, the treatment or modification of nucleic acid amplified using PCR so as to render it detectable, identifiable and/or quantifiable : which may include as its essential active reagents labeled primers, probes ( including binding partners or reporter molecules ), and fluorescent intercalating or tagging agents ; and/or ( d ) The syn thesis, purification, labeling, and/or immobilization of nucleic acid probes used in PCR ( i.e., one or more compounds that is / are : ( y ) composed of one or more nucleotides or analogs thereof ; or ( z ) capable of binding with one or more nucleotides or analogs thereof ) ; and/or ( e ) The control of contamination