Tissue (cell) antigens Medical Devices – Page 1

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 1	COMPLEXITY
Aperio ePathology eIHC IVD System – AT Turbo Analyte: Tissue (cell) antigens	HIGH
Aperio ePathology eIHC IVD System – AT Turbo Analyte: Tissue (cell) antigens	HIGH
Aperio ePathology eIHC IVD System – CS2 Analyte: Tissue (cell) antigens	HIGH
Aperio ePathology eIHC IVD System – CS2 Analyte: Tissue (cell) antigens	HIGH
Aperio IHC PR Breast Tissue Manual Read of Digital Slides Analyte: Tissue (cell) antigens	HIGH
Aperio ScanScope System Analyte: Tissue (cell) antigens	HIGH
Aperio ScanScope System Immunohistochemistry Estrogen/Progesterone Breast Tissue Image Analysis Analyte: Tissue (cell) antigens	HIGH
APPLIED IMAGING ARIOL Analyte: Tissue (cell) antigens	HIGH
APPLIED IMAGING ARIOL Analyte: Tissue (cell) antigens	HIGH
ASI GenASIs HiPath IHC Family For ER (SP1) Analyte: Tissue (cell) antigens	HIGH
ASI GenASIs HiPath IHC Family for HER2 (4B5) Analyte: Tissue (cell) antigens	HIGH
ASI GenASIs HiPath IHC Family for Ki-67 (30-9) Analyte: Tissue (cell) antigens	HIGH
ASI GenASIs HiPath IHC Family for PR (1E2) Analyte: Tissue (cell) antigens	HIGH
ASYMMETRX PROSTATE-63 CANCER DIAGNOSTIC REAGENT Analyte: Tissue (cell) antigens	HIGH
BIOGENEX SUPER SENSITIVE MULTILINK DETECTION SYSTEM Analyte: Tissue (cell) antigens	HIGH
BIOGENEX SUPER SENSITIVE MULTILINK DETECTION SYSTEM Analyte: Tissue (cell) antigens	HIGH
BIOGENEX SUPERSENSITIVE MULTILINK DETECTION SYSTEM (BIOGENEX LABORATORIES) Analyte: Tissue (cell) antigens	HIGH
BIOGENEX SUPERSENSITIVE MULTILINK DETECTION SYSTEM (BIOGENEX LABORATORIES) Analyte: Tissue (cell) antigens	HIGH
CELL ANALYSIS, INC. QUANTITATIVE CELLULAR ASSESSMENT (QCA) Analyte: Tissue (cell) antigens	HIGH
CellTracks Analyzer II Analyte: Tissue (cell) antigens	HIGH

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