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Factor II (Prothrombin) G20210A Kit

Detection and genotyping of a single point mutation of the human Factor II gene

An in vitro diagnostic test that allows the detection and genotyping of a single point mutation (G to A at position 20210) of the human Factor II gene from DNA isolated from human whole peripheral blood.

This test is performed on the LightCycler^® Instrument utilizing polymerase chain reaction (PCR) for the amplification of Factor II DNA recovered from clinical samples and fluorigenic target-specific hybridization for the detection and genotyping of the amplified Factor II DNA.

Intended use

(FDA-IVD)

The Factor II (Prothrombin) G20210A Kit allows the detection and genotyping of a single point mutation (G to A at position 20210) of the human Factor II gene from DNA isolated from human whole peripheral blood. The test is performed on the LightCycler® 1.2 Instrument utilizing (PCR) for the amplification of Factor II DNA recovered from clinical specimens and fluorogenic target-specific hybridization for the detection and genotyping of the amplified Factor II DNA. The Factor II (Prothrombin) G20210A test is an in vitro diagnostic test for the detection and genotyping of the Factor II (Prothrombin) G20210A mutation as an aid to diagnosis in the evaluation of patients with suspected thrombophilia. The test is intended to be used on the LightCycler® 1.2 Instrument using the LightCycler® Software 3.5. The specimen preparation must be performed according to the workflow procedures in the package insert.

Registration status

US-IVD