SKT-056 Cancer Antigen 15-3 (CA15-3) CLIA Kit

FDA registration

EPITOPE DIAGNOSTICS, INC.·1 product·🇺🇸 United States

KTR 874 Serolisa™ Human cFGF-21 ELISA Kit

FDA registration

EPITOPE DIAGNOSTICS, INC.·1 product·🇺🇸 United States

END EXPIRATORY FILTER, MODEL RT020

FDA 510(k)

FDA Class 2 ·Anesthesiology

AUROPAL, ORDER-NO.: 2101

FDA 510(k)

FDA Class 2 ·Dental

DIMENSION CLINICAL CHEMISTRY SYSTEM MPO FLEX REAGENT CARTRIDGE, CALIBRATOR,CONTROL, MODEL RF425, RC425,RC426

FDA 510(k)

FDA Class 2 ·Immunology

CARDIOMPO TEST

FDA 510(k)

FDA Class 2 ·Immunology

BAYER IMMUNO 1 HER-2/NEU ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

MANUAL HER-2/NEU MICROTITER ELISA (OSDI HER-2/NEU ELISA)

FDA 510(k)

FDA Class 2 ·Immunology

B·R·A·H·M·S CgA II KRYPTOR, B·R·A·H·M·S CgA II KRYPTOR CAL, B·R·A·H·M·S CgA II KRYPTOR QC

FDA 510(k)

FDA Class 2 ·Immunology

BAYER ADVIA CENTAUR HER-2/NEU ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF

FDA 510(k)

FDA Class 2 ·Immunology

Lumipulse G ß-Amyloid Ratio (1-42/1-40)

FDA 510(k)

FDA Class 2 ·Immunology

Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF

FDA 510(k)

FDA Class 2 ·Immunology

MAMMAPRINT

FDA 510(k)

FDA Class 2 ·Immunology

MAMMAPRINT

FDA 510(k)

FDA Class 2 ·Immunology

MODIFICATION TO MAMMAPRINT

FDA 510(k)

FDA Class 2 ·Immunology

CYFRA 21-1 EIA MODEL 211-10

FDA 510(k)

FDA Class 2 ·Immunology

MAMMAPRINT

FDA 510(k)

FDA Class 2 ·Immunology

PROSIGNA BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

MAMMAPRINT FFPE

FDA 510(k)

FDA Class 2 ·Immunology