Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker

FDA 510(k)

FDA Class 2 ·Immunology

Hevylite Human IgA Kappa Kit for use on SPAPLUS, Hevylite Human IgA Lambda Kit for use on SPAPLUS

FDA 510(k)

FDA Class 2 ·Immunology

MONO SCREENING TEST

FDA 510(k)

FDA Class 2 ·Immunology

CLINICAL ASSAYS GAMMACOAT [125I] FERRITIN IMMUNO.

FDA 510(k)

FDA Class 2 ·Immunology

RCRP Flex reagent cartridge

FDA 510(k)

FDA Class 2 ·Immunology

QUANTICLONE IGE RADIOIMMUNASSAY

FDA 510(k)

FDA Class 2 ·Immunology

VENTANA CD30 (Ber-H2) RxDx Assay

FDA 510(k)

FDA Class 2 ·Immunology

N-ASSAY TIA MULTI CRP CALIBRATOR SET

FDA 510(k)

FDA Class 2 ·Immunology

AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES

FDA 510(k)

FDA Class 2 ·Immunology

i-STAT TBI Cartridge with the i-STAT Alinity System

FDA 510(k)

FDA Class 2 ·Immunology

I-125 ANTI-THYROGLOBULIN ANTIBODY IRMA TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

RHEUMAJET CRP

FDA 510(k)

FDA Class 2 ·Immunology

IMMULITE TURBO MYOGLOBIN, MODELS LSKMY1, LSKMY5

FDA 510(k)

FDA Class 2 ·Immunology

Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF

FDA 510(k)

FDA Class 2 ·Immunology

ACCESS MYOGLOBIN REAGENTS

FDA 510(k)

FDA Class 2 ·Immunology

C-REACTIVE PROTEIN (CRP)

FDA 510(k)

FDA Class 2 ·Immunology

CARCINOEMBRYONIC ANTIGEN (CEA) CONTROL

FDA 510(k)

FDA Class 2 ·Immunology

OUCHTERLONY AGAR PLATES

FDA 510(k)

FDA Class 1 ·Immunology

CORDIA NP

FDA 510(k)

FDA Class 2 ·Immunology

HE4 EIA, MODEL: 404-10 US

FDA 510(k)

FDA Class 2 ·Immunology