Tissue (cell) antigens Medical Devices – Page 4

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

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Medical Device – Page 4	COMPLEXITY
Omnyx Manual Read of the Digital HER2 Application Analyte: Tissue (cell) antigens	HIGH
PATHIAM Imaging Software for Her2/neu Analyte: Tissue (cell) antigens	HIGH
PATHIAM System with iScan for Her2/neu Analyte: Tissue (cell) antigens	HIGH
PATHIAM System with iScan(TM) for Ki67 Analyte: Tissue (cell) antigens	HIGH
PATHIAM System with iScan(TM) for p53 Analyte: Tissue (cell) antigens	HIGH
Philips HER2/neu IHC Digital Manual Read Analyte: Tissue (cell) antigens	HIGH
Ventana AEC Detection Kit Analyte: Tissue (cell) antigens	HIGH
VENTANA Benchmark ULTRA Instrument Analyte: Tissue (cell) antigens	HIGH
Ventana Blue Alkaline Phosphatase Blue Detection Kit Analyte: Tissue (cell) antigens	HIGH
Ventana c-erbB-2 Primary Antibody (clone CB11) Analyte: Tissue (cell) antigens	HIGH
Ventana c-erbB-2 Primary Antibody (clone CB11) with Ventana ES Slide Staining System Analyte: Tissue (cell) antigens	HIGH
Ventana c-erbB-2 Primary Antibody (clone CB11) with Ventana Nexes Slide Staining System Analyte: Tissue (cell) antigens	HIGH
Ventana DAB Detection Kit Analyte: Tissue (cell) antigens	HIGH
VENTANA I-VIEW DAB DETECTION KIT Analyte: Tissue (cell) antigens	HIGH
Ventana Image Analysis System Analyte: Tissue (cell) antigens	HIGH
Ventana Image Analysis System Analyte: Tissue (cell) antigens	HIGH
Ventana Image Analysis System Analyte: Tissue (cell) antigens	HIGH
Ventana Image Analysis System Analyte: Tissue (cell) antigens	HIGH
Ventana Image Analysis System Analyte: Tissue (cell) antigens	HIGH
Ventana PATHWAY Anti-c-KIT (9.7) Primary Antibody Analyte: Tissue (cell) antigens	HIGH

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