Agilent HER2 IQFISH pharmDx (Dako Omnis)

Country: Սինգապուր

language: անգլերեն

source: HSA (Health Sciences Authority)

MAH:

AGILENT TECHNOLOGIES SINGAPORE (INTERNATIONAL) PTE LTD

class:

Class C IVD

manufactured_by:

Agilent Technologies Singapore (International) Pte Ltd

therapeutic_area:

Gastroenterology & Urology

therapeutic_indication:

HER2 IQFISH pharmDx (Dako Omnis) is the hybridization probe for the automated direct fluorescence in situ hybridization (FISH) assay onboard Dako Omnis instruments and is, together with accessory reagent devices, designed to quantitatively determine HER2 gene amplification in formalin-fixed, paraffin-embedded (FFPE) breast cancer tissue specimens and FFPE specimens from patients with adenocarcinoma of the stomach including gastro-esophageal junction. HER2 IQFISH pharmDx is indicated in adjunction to HercepTest™ in the assessment of patients for whom Herceptin™ (trastuzumab) treatment is being considered. For breast cancer patients, results from HER2 IQFISH pharmDx (Dako Omnis) are intended for use as an adjunct to the clinicopathologic information currently used for estimating prognosis in stage II, node-positive breast cancer patients.

leaflet_short:

Models: Dako Omnis - GI100, HER2 IQFISH pharmDx (Dako Omnis) - GM333, ISH Ethanol solution,96% (Dako Omnis) - GM300, ISH Pepsin (Dako Omnis) - GM302, ISH Pre-treatment solution (20x) (Dako Omnis) - GM301, ISH Stringent wash buffer (20x) (Dako Omnis) - GM303, Fluorescence mounting medium (Dako Omnis) - GM304

authorization_date:

2019-07-23