COMPLEXED PSA MICROTITER ELISA

FDA 510(k)

FDA Class 2 ·Immunology

OPUS PSA TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

ADVANTAGE CHEMILUMINESCENCE PROSTATE SPECIFIC ANTIGEN (PSA) IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Immunology

VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428

FDA 510(k)

FDA Class 2 ·Immunology

TOTAL PSA MICROTITER ELISA

FDA 510(k)

FDA Class 2 ·Immunology

BAYER PSA ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

ACTIVE PSA ELISA (DSL-10-9700)

FDA 510(k)

FDA Class 2 ·Immunology

THE COMPLEXED PSA ASSAY FOR THE BAYER IMMUNO 1 SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

BIOCIRCUITS IOS PROSTATE SPECIFIC ANTIGEN (PSA) TEST CARTRIDGES, BIOCIRCUITS IOS PSA CONTROLS

FDA 510(k)

FDA Class 2 ·Immunology

COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

NUCLEIC ACID DETECTION IMMUNOASSAY (NADIA) PSA ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

ACTOnco, ACTOnco IVD

FDA 510(k)

FDA Class 2 ·Pathology

“Genius™ Digital Diagnostics System with the Genius™ Cervical AI algorithm”

FDA 510(k)

FDA Class 2 ·Pathology

Philips IntelliSite Pathology Solution 5.1

FDA 510(k)

FDA Class 2 ·Pathology

NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets)

FDA 510(k)

FDA Class 2 ·Pathology

8MP Color LCD Displays C811W, C811WT, PA27 and PA27T

FDA 510(k)

FDA Class 2 ·Pathology

Sectra Digital Pathology Module (Version 3.3)

FDA 510(k)

FDA Class 2 ·Pathology

Philips IntelliSite Pathology Solution

FDA 510(k)

FDA Class 2 ·Pathology

MDPC-8127

FDA 510(k)

FDA Class 2 ·Pathology

HALO AP Dx

FDA 510(k)

FDA Class 2 ·Pathology