ORGENTEC ANTI-TPO ELISA

FDA 510(k)

FDA Class 2 ·Immunology

VENTRE/SPEC ALLERGEN CONTROL-INHALANT

FDA 510(k)

FDA Class 2 ·Immunology

Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit

FDA 510(k)

FDA Class 2 ·Microbiology

ALASTAT MICROPLATE MIXED ALLERGEN PANELS

FDA 510(k)

FDA Class 2 ·Immunology

K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)

FDA 510(k)

FDA Class 2 ·Immunology

TURBO-RAST SPECIFIC IGE ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

HARDYDISK, CEFOTAXIME 30MCG

FDA 510(k)

FDA Class 2 ·Microbiology

DIAZYME FERRITIN ASSAY, DIAZYME FERRITIN CALIBRATOR SET, DIAZYME FERRITIN CONTROL SET

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA LITE CHROMATIN ELISA

FDA 510(k)

FDA Class 2 ·Immunology

IMMUNOCHEMISTRY SYSTEM BETA-2-MICROGLOBULIN REAGENT

FDA 510(k)

FDA Class 2 ·Immunology

QuickVue Influenza A+B

FDA 510(k)

FDA Class 2 ·Microbiology

ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

QM300 CALIBRATOR F PACK

FDA 510(k)

FDA Class 2 ·Immunology

DRYSPOT INFECTIOUS MONONUCLEOSIS KIT

FDA 510(k)

FDA Class 2 ·Immunology

SAS INFLUENZA A TEST

FDA 510(k)

FDA Class 2 ·Microbiology

VDRL CARBON ANTIGEN TEST S900500, S900250 & S90010

FDA 510(k)

FDA Class 2 ·Microbiology

SPQ TEST SYSTEM FOR COMPLEMENT C3

FDA 510(k)

FDA Class 2 ·Immunology

PHADEBAS RAST PHADEZYM RAST ALLERGEN

FDA 510(k)

FDA Class 2 ·Immunology

IGX PLEX CELIAC QUALITATIVE ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

VARELISA MPO-ANCA

FDA 510(k)

FDA Class 2 ·Immunology