NOVA View Automated Fluorescense Microscope

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA LITE CELIAC DGP SCREEN

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA FLASH H-TTG IGG

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA LITE RIBOSOME P ELISA

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA FLASH ENA7

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA Flash CCP3, QUANTA Flash CCP3 Calibrators, and QUANTA Flash CCP3

FDA 510(k)

FDA Class 2 ·Immunology

NOVA GEL(TM) T SM/RNP

FDA 510(k)

FDA Class 2 ·Immunology

NOVA LITE(TM) DSDNA

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA PLEX CELIAC IGG PROFILE

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar Anti-B2GPI Domain 1, HemosIL AcuStar Anti-B2GPI Domain 1 Controls

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA PLEX ANCA PROFILE

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA LITE CMV IGG ELISA

FDA 510(k)

FDA Class 2 ·Microbiology

QUANTA LITE H.PYLORI IGA ELISA

FDA 510(k)

FDA Class 1 ·Microbiology

NOVA Lite DAPI ANA Kit

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA LITE B2 GPI SCREEN

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls

FDA 510(k)

FDA Class 2 ·Immunology

NOVA GEL(TM) SM/RNP

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGA ELISA

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA LITE CENTROMERE (CENP-A & CENP-B) ELISA

FDA 510(k)

FDA Class 2 ·Immunology