Vela Sentosa SQ Melanoma Panel

Maa: Singapore

Kieli: englanti

Lähde: HSA (Health Sciences Authority)

Saatavilla:

VELA OPERATIONS SINGAPORE PTE. LTD.

luokka:

Class C IVD

Valmistaja:

VELA OPERATIONS SINGAPORE PTE. LTD.

Terapeuttinen alue:

Immunology

Käyttöaiheet:

The Sentosa SQ Melanoma Panel is a next generation sequencing-based in vitro diagnostic test that simultaneously detects hot spot mutations in 10 genes from formalin-fixed paraffin-embedded (FFPE) samples that have previously demonstrated clinical relevance in the management of patients with melanoma. This panel is intended to be used on the Sentosa SX101 with the Sentosa SX FFPE II gDNA Kit in conjunction with the Sentosa ST401 and Sentosa SQ301 instruments. The Sentosa SQ Melanoma Panel is intended to be used as a test to aid the oncologist in clinical decision-making. Results should be used in conjunction with other available laboratory and clinical information and are not intended for use as a stand-alone diagnostic test or disease monitoring.

Tuoteyhteenveto:

Device System Info:[System or Procedure Pack], IVD system with analyzers; Models: Sentosa SQ Melanoma Panel (4x8) - 690008, Sentosa SQ Melanoma Reagents - 300335, Sentosa SQ Oncology Solutions - 300336, Sentosa SX FFPE II gDNA Kit (4x8) - 300230, Sentosa SX101 instrument - 400089, Sentosa SX101 Software - 460018, Sentosa ST401i - 400124, Sentosa ST401e - 400120, Sentosa SQ301 Sequencer - 400103, Sentosa SQ Reporter software - 480004, Sentosa ST Template Kit - 690006, Sentosa ST Template Solutions - 300324, Sentosa ST Template Supplies - 300327, Sentosa ST Template Reagents - 300318, Sentosa ST Template Beads - 300321, Sentosa SQ Sequencing Kit - 690004, Sentosa SQ Sequencing Supplies - 300309, Sentosa SQ Sequencing Reagents - 300311, Sentosa SQ Sequencing Solutions - 300315, Sentosa SQ318 Chip Kit - 300302, Sentosa ST Powercord (240V) - 400155, Sentosa ST Rack Kit - 400136, Sentosa ST Solutions Rack - 400162, Sentosa ST Assembly Rack - 400160, Sentosa ST Sample Rack - 400161, Sentosa SQ Reporter (Perpetual) - 400133, Sentosa Link Software - 400045, Sentosa SQ301 Server and Sentosa SQ Suite software - 400102, Ion PGM Dx Chip Minifuge - 4486175

Valtuutus päivämäärä:

2017-07-13