IMMULITE 2000 ANTI-CCP IGG ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE ELISA, MODEL FCCP 200

FDA 510(k)

FDA Class 2 ·Immunology

ELIA CCP, MODEL 14-5515-01; ELIA CCP CONTROL, MODEL 83-1009-01

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA Flash CCP3, QUANTA Flash CCP3 Calibrators, and QUANTA Flash CCP3

FDA 510(k)

FDA Class 2 ·Immunology

THERATEST EL-ANTI-CCP/2

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA LITE CCP3 IGG ELISA

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA LITE CCP ELISA

FDA 510(k)

FDA Class 2 ·Immunology

MULTI-ANALYTE DETECTION SYSTEMS

FDA 510(k)

FDA Class 2 ·Immunology

IMMUNOSCAN CCPLUS

FDA 510(k)

FDA Class 2 ·Immunology

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

FDA 510(k)

FDA Class 2 ·Immunology

AXIS-SHIELD ANTI-CCP

FDA 510(k)

FDA Class 2 ·Immunology

BIOPLEX 2200 ANTI-CCP KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

ROCHE ELECSYS ANTI-CCP IMMUNOASSAY, ROCHE ELECSYS PRECICONTROL ANTI-CCP

FDA 510(k)

FDA Class 2 ·Immunology

UNIVERSAL BITE BLOCK

FDA 510(k)

FDA Class 2 ·Neurology

I-Motion

FDA 510(k)

FDA Class 2 ·Physical Medicine

HPD HUMIDIFYING CHAMBER

FDA 510(k)

FDA Class 2 ·Anesthesiology

WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401

FDA 510(k)

FDA Class 2 ·Immunology

1870T PRESSURE TRANSDUCER PRE-AMPLIFIER, 1880 WATE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

URODYNAMIC CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology