EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic™ EUROPattern

FDA 510(k)

FDA Class 2 ·Immunology

AUTOFLUOR V

FDA 510(k)

FDA Class 2 ·Immunology

HY-TEC/MANUAL AUTOIMMUNE KIT FOR MITOCHONDRIA

FDA 510(k)

FDA Class 2 ·Immunology

CPA 125 II ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229

FDA 510(k)

FDA Class 2 ·Immunology

EU-TTG IGA ELISA

FDA 510(k)

FDA Class 2 ·Immunology

VIRGO BETA 2 GLYCOPROTEIN IGM ANTIBODY KIT

FDA 510(k)

FDA Class 2 ·Immunology

AGGLUTINOTEST-INFECTIOUS MONONUCLEOSIS

FDA 510(k)

FDA Class 2 ·Immunology

MEDICA II-F-ASMA TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

LD-1

FDA 510(k)

FDA Class 1 ·Immunology

IMMULITE(R) ALLERGY FOOD PANEL FP5E

FDA 510(k)

FDA Class 2 ·Immunology

OPTILITE C1 INACTIVATOR KIT

FDA 510(k)

FDA Class 2 ·Immunology

ORGENTEC ANTI-SS-B(LA) PIN IMMUNO ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit

FDA 510(k)

FDA Class 2 ·Immunology

PHADEBAS/PHADEZYM IGE REAGENTS

FDA 510(k)

FDA Class 2 ·Immunology

MANUAL HER-2/NEU MICROTITER ELISA (OSDI HER-2/NEU ELISA)

FDA 510(k)

FDA Class 2 ·Immunology

DNP EIA DIAGNOSTIC KIT

FDA 510(k)

FDA Class 2 ·Immunology

ANTI-HISTONE ANIBODY TEST

FDA 510(k)

FDA Class 2 ·Immunology

AFP ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

RHEUMELISA ASSAY FOR SS-B/LA AUTOANTIBODIES

FDA 510(k)

FDA Class 2 ·Immunology