P53

Primary DI

D-9020B4

Basic UDI-DI Code

B-9020B4

Reference

RC-TP53096-I

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

No Longer On The Market

Manufacturer

NimaGen BV

The intended purpose of this assay is NGS library preparation for Illumina® sequencing of the human TP53 gene coding exons, including a minimum of 20 bases upstream and downstream of each exon; to aid in diagnosis and or prognostication of cancer by detecting acquired mutations within the TP53 gene; to aid in diagnosis of congenital predisposition to cancer by detection of germline mutations in the TP53 gene (Li-Fraumeni syndrome). The lower detection limit of this assay is 5% variant allele frequency. The assay is designed for use with DNA extracted from peripheral blood or tumour tissue. Specimens should have an absorbance ratio (260/280) of ~1.8, regardless of the extraction method used. The assay provides reagents for Multiplex Amplicon based NGS library preparation and is for professional use only. The kit is based on the patented Reverse Complement PCR technology, providing a safe, robust and simple workflow, combining multiples amplification in a single reaction, decreasing risk for PCR contamination and sample swapping.

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).