ABBOTT AXSYM ANTI-THYROID-PEROXIDASE, MODELS5F57 COMPRISING STANDARDS/CALIBRATORS

FDA 510(k)

FDA Class 2 ·Immunology

DIASTAT ANTI-HISTONE KIT

FDA 510(k)

FDA Class 2 ·Immunology

DIASTAT ANTI-NUCLEAR ANTIBODY (ANA) KIT

FDA 510(k)

FDA Class 2 ·Immunology

DIASTAT ANTI-THYROGLOBULIN KIT

FDA 510(k)

FDA Class 2 ·Immunology

Alere NT-proBNP for Alinity i Reagent Kit

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIASTAT ANTI-JO-1 KIT

FDA 510(k)

FDA Class 2 ·Immunology

ADVIA Centaur Calcitonin (CALCT) assay

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AXSYM ANTI-CCP REAGENT, STANDARD CALIBRATOR AND CONTROL KITS, MODELS 3L91-20, 3L91-01 AND 3L91-10

FDA 510(k)

FDA Class 2 ·Immunology

ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

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