An antibody, specific receptor protein, ligand, nucleic acid sequence (e.g., primer, probe) or similar reagent, which through specific binding or chemical reaction with an intended target, is used to identify or quantify a chemical substance in a biological...
A reagent intended to be used in combination with sequence-specific primers, probes and/or controls to facilitate the amplification of a target nucleic acid sequence [i.e., deoxyribonucleic acid (DNA) or ribonucleic acid (RNA)} in a clinical specimen, using...
A collection of oligonucleotide probes intended to be used for the simultaneous hybridization of multiple amplified nucleic acid targets from a clinical specimen, for subsequent genome or transcriptome analyses [e.g., single nucleotide polymorphisms (SNPs) ...
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay intended to be used for the generic detection of nucleic acid (e.g., DNA, RNA) probes hybridized to their target nucleotide sequences in a clin...
A collection of reagents and other associated materials intended to be used in combination with sequence-specific primers, probes and/or controls to facilitate the amplification of a target nucleic acid sequence [i.e., deoxyribonucleic acid (DNA) or ribonuc...
A collection of reagents and other associated materials intended to be used to generate a chemiluminescent signal when performing an assay using a nucleic acid technique (NAT) on a clinical specimen. The kit is typically used in conjunction with luminescent...
A collection of reagents and other associated materials intended to be used for the detection of nucleic acid (e.g., DNA, RNA) probes [not included] hybridized to their target nucleotide sequences in a clinical specimen. It may be based on different techniq...
A mains electricity (AC-powered) laboratory instrument intended to be used for the processing of a prepared clinical specimen with an immobilized probe on a solid phase (e.g. blotting membrane or gel sheet) for blot assays (e.g. line assays, Western, Southe...
A collection of reagents and other associated materials [enzymes, buffers, nucleotides, magnesium chloride (MgCl2)], intended to be used in combination with sequence-specific primers, probes and/or controls (not included) to facilitate the amplification of ...