23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia

FDA 510(k)

FDA Class 2 ·Immunology

VENTREZYME VAST IMMUNO-PEROXIDASE ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

ELISA COMBI-KIT HUMAN IGG SUBCLASSES

FDA 510(k)

FDA Class 2 ·Immunology

RETINOL BINDING RID KIT

FDA 510(k)

FDA Class 1 ·Immunology

VENTRE/SEP IGE RIA TEST SET

FDA 510(k)

FDA Class 2 ·Immunology

MODIFICATION TO REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTATIVE TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

HYTEC AUTOIMMUNE KITS (SS-B)

FDA 510(k)

FDA Class 2 ·Immunology

CARDIOLIPIN G EIA TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

ORGENTEC ANTI-SS-A(RO) ELISA

FDA 510(k)

FDA Class 2 ·Immunology

ANTINUCLEAR ANTIBODY SCREEN FLOURESC

FDA 510(k)

FDA Class 2 ·Immunology

ALLERGEN CONTROL INHALENT

FDA 510(k)

FDA Class 2 ·Immunology

C3 ANTISERUM CONTROL

FDA 510(k)

FDA Class 2 ·Immunology

Optilite Rheumatoid Factor Kit

FDA 510(k)

FDA Class 2 ·Immunology

RADIAL IMMUNO-DIFFUSION PLATES IGA, IGD, IGG & IGM

FDA 510(k)

FDA Class 2 ·Immunology

COBAS(R) CORE IGE TOTAL EIA

FDA 510(k)

FDA Class 2 ·Immunology

TAGO FIFFU-GEN, OROSOMUCOID

FDA 510(k)

FDA Class 1 ·Immunology

AUTOSTAT II RHEUMATOID FACTOR IGM ELISA

FDA 510(k)

FDA Class 2 ·Immunology

ORGENTEC ANTI-CARDIOLIPIN ELISA ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

EU-TTG IGA AND EU-TTG IGG

FDA 510(k)

FDA Class 2 ·Immunology

QUANTIMETRIC PLUS C3 REAGENT KIT

FDA 510(k)

FDA Class 2 ·Immunology