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Scimed (Asia) Pte Ltd
Class C IVD
Obstetrics & Gynaecology
The AmplideX™ FMR1 PCR Kit is an in vitro diagnostic device for professional use in clinical laboratories to amplify and detect the cytosine-guanine-guanine (CGG) repeat region in the 5’-untranslated region of the fragile X mental retardation-1 (FMR1) gene. The device is intended as an aid in diagnosis of fragile X syndrome and fragile X associated disorders, e.g. tremor and ataxia syndrome (FX-TAS) and primary ovarian insufficiency (FX-POI), through determination of CGG repeat length up to 200 CGG and detection of alleles greater than 200 CGG. The test consists of a polymerase chain reaction (PCR) of genomic DNA purified from whole blood followed by fragment sizing on a general laboratory-validated genetic analyzer or capillary electrophoresis platform and conversion of product size to the number of CGG repeats.