Agilent HER2 IQFISH pharmDx

Land: Singapore

Taal: Engels

Bron: HSA (Health Sciences Authority)

Beschikbaar vanaf:

AGILENT TECHNOLOGIES SINGAPORE (INTERNATIONAL) PTE LTD

klasse:

Class C IVD

Geproduceerd door:

Agilent Technologies Singapore (International) Pte Ltd

Therapeutisch gebied:

Gastroenterology & Urology

therapeutische indicaties:

HER2 IQFISH pharmDx is a direct fluorescence in situ hybridization (FISH) assay 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 are intended for use as an adjunct to the clinicopathologic information currently used for estimating prognosis in stage II, node-positive breast cancer patients.

Product samenvatting:

Models: HER2 IQFISH pharmDx - K5731

Autorisatie datum:

2019-07-23