Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpertInfinity-80 systems), Xpert Vaginal/Endocervical Specimen Collection Kit, and Xpert Urine Specimen Collection Kit

FDA 510(k)

FDA Class 2 ·Immunology

CELLSEARCH CIRCULATING TUMOR CELL KIT

FDA 510(k)

FDA Class 2 ·Immunology

HYCOR HY.TEC/MANUAL SS-B AUTO-ANTIBODY

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA LITE IGA GLIADIN ELISA

FDA 510(k)

FDA Class 2 ·Immunology

PLAC TEST FOR LP-PLA2 ACTIVITY

FDA 510(k)

FDA Class 2 ·Immunology

IMMULITE ANTI-TG AB

FDA 510(k)

FDA Class 2 ·Immunology

K-ASSAY IGG

FDA 510(k)

FDA Class 2 ·Immunology

Diazyme PLAC® Test for Lp-PLA2 Activity

FDA 510(k)

FDA Class 2 ·Immunology

LA EIA TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

VARELISA HISTONE ANTIBODIES

FDA 510(k)

FDA Class 2 ·Immunology

CRP

FDA 510(k)

FDA Class 2 ·Immunology

BOEHRINGER MANNHEIM TINA-QUANT IGE TEST

FDA 510(k)

FDA Class 2 ·Immunology

MICROMEDIC FERRITIN IRMA KIT

FDA 510(k)

FDA Class 2 ·Immunology

PHADEBAS & PHADEZYM RAST TEST ALLERG

FDA 510(k)

FDA Class 2 ·Immunology

CRPEX-HS C-REACTIVE PROTEIN LIT ASSAY, CATALOG NO. 1010

FDA 510(k)

FDA Class 2 ·Immunology

ENZYME IMMUNOASSAY ENA PLUS SCREENING TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

IMMUNOCAP RAPID INHALANT PROFILE , IMMUNOCAP RAPID READER, IMMUNOCAP RAPID READER CHECK DEVICE, AND IMMUNOCAP RAPID QC1

FDA 510(k)

FDA Class 2 ·Immunology

COBAS INTEGRA REAGENT CASSETTE FOR RHEUMATOID FACTOR II

FDA 510(k)

FDA Class 2 ·Immunology

Helix Genetic Health Risk App for late-onset Alzheimer’s disease

FDA 510(k)

FDA Class 2 ·Immunology

COULTER CLONE GAM-FITC POLY ANTI (IGG & IGM)

FDA 510(k)

FDA Class 2 ·Immunology