Device typeNucleic acid amplification mastermix kit IVD: 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 a target nucleic acid sequence [i.e., deoxyribonucleic acid (DNA) or ribonucleic acid (RNA)] in a clinical specimen, using a nucleic acid amplification technique [e.g., polymerase chain reaction (PCR), loop-mediated isothermal amplification (LAMP)].
FDA categoryDrug Metabolizing Enzyme Genotyping Systems
Device IDG257ASM001160
AvailabilityPrescription
Single useYes
MRI safetyLabeling does not contain MRI Safety Information