definiens: means any kit, reagent or group of reagents Sold together or separately, which will provide an End -User customer with the essential active reagents necessary to perform one or more of the following processes in conne ction with the practice of PCR : ( a ) Sample preparation, that is, the treatment of a sample in order to render a nucleic acid therein amplifiable : such a Component System may have as its essential active reagents, for example, the cell lysing, stabilization and/or precipitation reagents essential to expose and prepare DNA for amplification ; ( b ) The amplification of one or more designated nucleic acid sequences : such a Component System may have as its essential active reagents, for ex ample, the oligonucleotides and/or nucleotides, enzymes, buffers and associated co -reactants essential to perform amplification of nucleic acid using PCR ; and/or ( c ) Detection, that is, the treatment or modification of an amplified nucleic acid so as to render it detectable, identifiable and/or quantifiable : such a Component System may include labeled primers, probes, fluorescent intercalating or tagging agents, and any device provided therewith to enable the detection, identification or quantif ication of the nucleic acid