Asuragen AmplideX FMR1 PCR Kit

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Available from:

SCIMED (ASIA) PTE LTD

Class:

Class C IVD

Manufactured by:

Asuragen, Inc

Therapeutic area:

Obstetrics & Gynaecology

Therapeutic indications:

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.

Product summary:

Models: AmplideX FMR1 PCR Kit - 76008

Authorization date:

2015-04-06