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

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

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

Elegant™ Advanced CompHort

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

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