HER-2/NEU gene Medical Devices – Page 1

Below is a list of medical devices and their corresponding complexity (CLIA WAIVED, MODERATE, or HIGH) when testing for HER-2/NEU gene. Note that there may be additional pages of medical devices which test for HER-2/NEU gene to choose from located at the bottom of the list.

Medical Device – Page 1	COMPLEXITY
Aperio IHC HER2 Breast Tissue Manual Read of Digital Slides Analyte: HER-2/NEU gene	HIGH
Aperio ScanScope XT System Analyte: HER-2/NEU gene	HIGH
Applied Spectral Imaging GenASIs Scan and Analysis HER2/neu Analyte: HER-2/NEU gene	HIGH
Applied Spectral Imaging ScanView 6.0 Analyte: HER-2/NEU gene	HIGH
BAYER ADVIA:CENTAUR Analyte: HER-2/NEU gene	MODERATE
BAYER IMMUNO 1 SYSTEM Analyte: HER-2/NEU gene	MODERATE
Bioview Ltd. Duet System Analyte: HER-2/NEU gene	HIGH
Bioview Ltd. Duet System (Version 3.5) Analyte: HER-2/NEU gene	HIGH
Ikonisys, Inc. Ikoniscope oncoFISH Analyte: HER-2/NEU gene	HIGH
Invitrogen SPOT-Light HER2 CISH Kit Analyte: HER-2/NEU gene	HIGH
Leica Bond Oracle Anti-HER-2/Neu (CB11) Analyte: HER-2/NEU gene	HIGH
Olympus Virtual Slide System, VS800 for VS800HER2MR Analyte: HER-2/NEU gene	HIGH
ONCOR INFORM HER-2/NEU GENE DETECTION SYSTEM Analyte: HER-2/NEU gene	HIGH
SIEMENS ADVIA Centaur Analyte: HER-2/NEU gene	MODERATE
Siemens ADVIA Centaur CP System Analyte: HER-2/NEU gene	MODERATE
Siemens ADVIA Centaur XP System Analyte: HER-2/NEU gene	MODERATE
Ventana INFORM HER2 Dual ISH DNA Probe Cocktail Analyte: HER-2/NEU gene	HIGH

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