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MGB Alert IC2 Internal Control Template (250uL volume)
The MGB Alert Internal Control IC2 Template consists of a DNA plasmid intended for use as an unassayed internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The IC2 Internal Control can be used to detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The internal control is not intended to monitor other real-time PCR processes.
Details
Device typeNucleic acid amplification primer IVD: A defined piece of single-stranded nucleic acid intended to be used to initiate the amplification of a specific target nucleotide sequence at a single-gene locus or whole/partial chromosome level in a clinical specimen, using a nucleic acid amplification technique (e.g., polymerase chain reaction (PCR), loop-mediated isothermal amplification (LAMP)]. It is typically used to detect and/or identify chromosomal abnormalities (e.g., aneuploidy, deletion, translocation, duplication, inversion, gene insertion).
FDA categoryInternal Polymerase Chain Reaction Control, Not Assay Specific
Device ID03661540952401
MRI safetyLabeling does not contain MRI Safety Information