NOVA LITE(TM) ANA

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA LITE ENA ELISA

FDA 510(k)

FDA Class 2 ·Immunology

AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000

FDA 510(k)

FDA Class 2 ·Immunology

NOVA LITE ENDOMYSIAL

FDA 510(k)

FDA Class 2 ·Immunology

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

FDA 510(k)

FDA Class 2 ·Immunology

NOVA LITE(TM) SA

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA LITE PR3

FDA 510(k)

FDA Class 2 ·Immunology

NOVA GEL(TM) JO-1

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA LITE RF IGM

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA LITE TPO ELISA

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA LITE H-TTG/DGP SCREEN

FDA 510(k)

FDA Class 2 ·Immunology

NOVA GEL(TM) T SCL-70

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA FLASH ¿2GP1-DOMAIN1; CONTROLS, HEMOSIL ACUSTAR ANTI-¿2GPI DOMAIN1; CONTROLS.

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA Flash Calprotectin and Fecal Extraction Device

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA LITE B2 GPI IGA

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) Controls

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA LITE REBELLA IGG

FDA 510(k)

FDA Class 2 ·Microbiology

Aptiva® APS IgM Controls

Basic UDI-DI

EU IVDR · Eu Ivd Class B ·Inova Diagnostics. Inc.·1 device

Aptiva® APS IgM Calibrators

Basic UDI-DI

EU IVDR · Eu Ivd Class B ·Inova Diagnostics. Inc.·1 device

Aptiva® APS IgM Reagent

Basic UDI-DI

EU IVDR · Eu Ivd Class B ·Inova Diagnostics. Inc.·1 device