IMMUNODOT(R) ENA/DNA AUTOIMMUNITY SCREENING PANEL

FDA 510(k)

FDA Class 2 ·Immunology

NOVA LITE(TM) AUTOANTIBODY CONTROLS

FDA 510(k)

FDA Class 2 ·Immunology

SYNELISA SCL-70 ANTIBODIES

FDA 510(k)

FDA Class 2 ·Immunology

ENCORE SS-B

FDA 510(k)

FDA Class 2 ·Immunology

ENA EIA TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

FIDISTM CONNECTIVE 10, FIDISTM ANALYZER, CARIS

FDA 510(k)

FDA Class 2 ·Immunology

SERAQUEST ANTI-SSB

FDA 510(k)

FDA Class 2 ·Immunology

Aptiva CTD Essential Reagent

FDA 510(k)

FDA Class 2 ·Immunology

THE APTUS (AUTOMATED) APPLICATION OF THE JO-1 ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE

FDA 510(k)

FDA Class 2 ·Immunology

ANTI-DSDNA ANTIBODY TEST

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols

FDA 510(k)

FDA Class 2 ·Immunology

ENAII TEST KIT(SS-A(RO) & SS-B(LA) AUTOANTIBODY

FDA 510(k)

FDA Class 2 ·Immunology

HYTEC AUTOIMMUNE KIT (JO-1)

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA PLEX ENA PROFILE 6

FDA 510(k)

FDA Class 2 ·Immunology

IS-ANTI-JO-1 TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

DIASTAT ENA SINGLE WELL SCREEN KIT

FDA 510(k)

FDA Class 2 ·Immunology

ENCORE ENA COMBINED EIA

FDA 510(k)

FDA Class 2 ·Immunology

IS-ANTI-SM/RNP (720-270)

FDA 510(k)

FDA Class 2 ·Immunology

HEMAGEN ENA SCREENING KIT (EIA METHOD)

FDA 510(k)

FDA Class 2 ·Immunology

KALLESTAD SSA/SSB ENA TEST REAGENTS

FDA 510(k)

FDA Class 2 ·Immunology