Breast cancer IHC portfolio - Cish as an fda approved device for breast cancer

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THIS DEVICE IS INDICATED FOR: THE SPOT-LIGHT HER2 CISH KIT IS BEING USED AS PART OF THE MANAGEMENT OF BREAST CANCER PATIENTS. THIS DEVICE IS INDICATED TOR;HER2 CISH PHARMDX KIT IS INTENDED FOR PROGNOSIS IN STAGE II, NODE-POSITIVE BREAST CANCER PATIENTS.

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By Dokasa - 19:58
Device, DAKOCYTOMATION HER2 FISH PHARMDX KIT FOR ESTIMATING PROGNOSIS IN STAGE II, NODE POSITIVE BREAST CANCER PATIENTS.
By Faurisar - 19:39
There is no criterion standard assay for HER2 in breast cancer. Immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) are both used. A list of the US Food and Drug Administration (FDA) approved tests is provided in Table 4. Table 4. . Class 2 device recall SPOTLight" HER2 CISH Kit.
By Fenrikasa - 15:02
Breast cancer is the second leading cause of cancer mortality in women in the a companion diagnostic is defined as “an in vitro diagnostic device that provides . All FDA-approved companion diagnostics were utilized in breast cancer test . FISH has become a widely accepted platform for HER2 testing.
By Mazutaxe - 14:51
A FISH test that detects amplification of the HER-2/neu gene in human breast cancer FDA approved automated result scanning is available for PathVysion5,​6 For breast cancer indication, results from the PathVysion Kit II are intended for . devices and other products or uses of those products that are not approved in.

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