AMIZYME-ANDNA TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

ORGENTEC ANTI-SM ELISA

FDA 510(k)

FDA Class 2 ·Immunology

ANA PROFILE I

FDA 510(k)

FDA Class 2 ·Immunology

RO EIA TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

KALESTAD ANA MICROPLATE EIA

FDA 510(k)

FDA Class 2 ·Immunology

VARELISA RECOMBI ANA PROFILE, MODEL 18496

FDA 510(k)

FDA Class 2 ·Immunology

ENZYME ANTINUCLEAR ANTIBODY SCREENING TEST

FDA 510(k)

FDA Class 2 ·Immunology

AUTOANTIBODY PROFILE-6 ELISA TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

ANTINUCLEAR ANTIBODY (ANA) SCREENING TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

IMMUNODOT AUTOIMMUNE SCREENING PANEL 1

FDA 510(k)

FDA Class 2 ·Immunology

HEMAGEN ENA [RNP/SM] KIT (EIA METHOD)

FDA 510(k)

FDA Class 2 ·Immunology

ORGENTEC ANTI-RNP/SM ELISA

FDA 510(k)

FDA Class 2 ·Immunology

RHEUMELISA ASSAY FOR SS-A/RO AUTOANTIBODIES

FDA 510(k)

FDA Class 2 ·Immunology

ORGENTEC ANTI-SS-A(RO) PIN IMMUNO ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

HY-TEC/MANUAL AUTOIMMUNE KIT FOR HISTONE

FDA 510(k)

FDA Class 2 ·Immunology

SS-DNA EIA DIAGNOSTIC KIT

FDA 510(k)

FDA Class 2 ·Immunology

MARDX MITOCHONDRIA EIA TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

THERATEST EL-ANA PROFILES TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

VARELISA HISTONE ANTIBODIES, MODEL 16496

FDA 510(k)

FDA Class 2 ·Immunology

VARELISA RECOMBI CTD SCREEN, MODEL 13096

FDA 510(k)

FDA Class 2 ·Immunology