MODIFICATION OF MONO-PLUS(TM)

FDA 510(k)

FDA Class 2 ·Immunology

ALBUMIN IN SERUM

FDA 510(k)

FDA Class 2 ·Immunology

ALLERCOAT ALLERGEN DISCS

FDA 510(k)

FDA Class 2 ·Immunology

ENA SCREENING CIE KIT FOR DIAGNOSTIC USE

FDA 510(k)

FDA Class 2 ·Immunology

ABBOTT AXSYM ANTI-THYROGLOBULIN, MODELS 5F5B COMPRISING STANDARD/CALIBRATORS

FDA 510(k)

FDA Class 2 ·Immunology

FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2

FDA 510(k)

FDA Class 2 ·Immunology

TFR

FDA 510(k)

FDA Class 2 ·Immunology

ANTI-GLOBULIN CONTROL

FDA 510(k)

FDA Class 2 ·Immunology

CAT EPITHELIUM ALLERGEN DISC

FDA 510(k)

FDA Class 2 ·Immunology

N LATEX CRP MONO REAGENT

FDA 510(k)

FDA Class 2 ·Immunology

DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEM

FDA 510(k)

FDA Class 2 ·Immunology

INDIRECT FLUORESCENCE ASSAY FOR ANTI-NUCLEAR ANTIBODIES IGG ANTIBODY

FDA 510(k)

FDA Class 2 ·Immunology

NOVA LITE(TM) ANA PLUS

FDA 510(k)

FDA Class 2 ·Immunology

C4 ANTIGEN ANTIBODY CONTROL

FDA 510(k)

FDA Class 2 ·Immunology

CA 125 II ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

HUMAN C4 COMPLEMENT CONTROL SERUM

FDA 510(k)

FDA Class 2 ·Immunology

K-ASSAY IGM

FDA 510(k)

FDA Class 2 ·Immunology

MICROALBUMINURIA ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

HEMAGEN ENA DSDNA KIT (EIA METHOD)

FDA 510(k)

FDA Class 2 ·Immunology

Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit

FDA 510(k)

FDA Class 2 ·Immunology