DIASTAT ENA SINGLE WELL SCREEN KIT

FDA 510(k)

FDA Class 2 ·Immunology

DIASTAT ANTI-MPO (PANCA) KIT

FDA 510(k)

FDA Class 2 ·Immunology

ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C

FDA 510(k)

FDA Class 2 ·Hematology

AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIASTAT ANTI-PR3 (C-ANCA) KIT

FDA 510(k)

FDA Class 2 ·Immunology

ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials.

FDA 510(k)

FDA Class 2 ·Immunology

SHIELD DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGG (ELISA) ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

DIASTAT ANTI-THYROID PEROXIDASE KIT

FDA 510(k)

FDA Class 2 ·Immunology

SPIRAL FLOW PERIPHERAL VASCULAR GRAFT

FDA 510(k)

FDA Class 2 ·Cardiovascular

DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGM, MODEL FBGP 100M

FDA 510(k)

FDA Class 2 ·Immunology

AXIS-SHIELD ANTI-CCP

FDA 510(k)

FDA Class 2 ·Immunology

QUANTASE PHENYLALANINE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIASTAT TOTAL ANTI-CARDIOLIPIN KIT

FDA 510(k)

FDA Class 2 ·Immunology

SHIELD ACTIVATED FACTOR XII (ELISA) ASSAY

FDA 510(k)

FDA Class 2 ·Hematology

CARIESCAN PRO

FDA 510(k)

FDA Class 2 ·Dental

SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200

FDA 510(k)

FDA Class 2 ·Hematology

ABBOTT AXSYM B-TYPE NATRIURETIC PEPTIDE (BNP) MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

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

FDA 510(k)

FDA Class 2 ·Immunology

ADVIA Centaur Erythropoietin (EPO) assay

FDA 510(k)

FDA Class 2 ·Hematology

ARCHITECT Active-B12 (Holotranscobalamin)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry