Dako HER2 IQFISH pharmDx

Singapore - English - HSA (Health Sciences Authority)

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Available from:
SPD SCIENTIFIC PTE LTD
Class:
Class C IVD
Manufactured by:
Dako Denmark A/S
Therapeutic area:
Gastroenterology & Urology
Therapeutic indications:
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 summary:
Models: HER2 IQFISH pharmDx - K5731
Authorization number:
DE0503394
Authorization date:
2019-07-23

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