ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35

FDA 510(k)

FDA Class 2 ·Immunology

AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS

FDA 510(k)

FDA Class 2 ·Hematology

DISTAT ANTI-DSDNA KIT

FDA 510(k)

FDA Class 2 ·Immunology

REMOTE VIEW SOFTWARE

FDA 510(k)

FDA Class 2 ·Dental

DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE ELISA, MODEL FCCP 200

FDA 510(k)

FDA Class 2 ·Immunology

DIASTAT ANTI-CARDIOLIPIN KIT

FDA 510(k)

FDA Class 2 ·Immunology

AXIS-SHIELD ACVTIVE-B12

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SHIELD VON WILLEBRAND FACTOR ACTIVITY (ELISA) ASSAY

FDA 510(k)

FDA Class 2 ·Hematology

DIASTAT ANTI-MITOCHONDRIAL ANTIBODY KIT

FDA 510(k)

FDA Class 2 ·Immunology

DIASTAT ANTI-CENTROMERE KIT

FDA 510(k)

FDA Class 2 ·Immunology

AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIASTAT ANTI-CARDIOLIPIN KIT

FDA 510(k)

FDA Class 2 ·Immunology

AXSYM HOLO TC REAGENT KIT, MODEL 3L83-20; STANDARD CALIBRATOR KIT, MODEL 3L83-01; CONTROL KIT, MODEL 3L83-10

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Small Volume 0.2mL Syringe

FDA 510(k)

FDA Class 2 ·General Hospital

DIASTAT ANTI-CARDIOLIPIN IGG/IGM, MODEL FCAR 600

FDA 510(k)

FDA Class 2 ·Immunology

DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KIT

FDA 510(k)

FDA Class 2 ·Immunology

DISTAT ANTI-SCL-70 KIT

FDA 510(k)

FDA Class 2 ·Immunology

DIASTAT ANTI-THYROID PEROXIDASE ELISA MODEL #300

FDA 510(k)

FDA Class 2 ·Immunology

WALLACE (SURE VIEW) EMBRYO REPLACEMENT CATHETER AND TRIAL TRANSFER CATHETER

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry