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

FDA 510(k)

FDA Class 2 ·Immunology

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

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

DIASTAT TOTAL ANTI-CARDIOLIPIN, MODEL FCAR 100T

FDA 510(k)

FDA Class 2 ·Immunology

PHARMA-PLAST CLINIPAK

FDA 510(k)

FDA Class 2 ·General Hospital

SupaScoota Motorized vehicle - Spartan (Sumo)/ Spartan SP (Sumo SP)

FDA 510(k)

FDA Class 2 ·Physical Medicine

ASIK 'ONCE' SYRINGE

FDA 510(k)

FDA Class 2 ·General Hospital

1-M GRADUATED COMPRESSION ANTI-EMBOLISM STOCKING, MODEL SS-811, SS-508, SS-613

FDA 510(k)

FDA Class 2 ·General Hospital

PHARMA-PLAST NEEDLE

FDA 510(k)

FDA Class 2 ·General Hospital

PHARMA-PLAST INSULIN INFUSION SET

FDA 510(k)

FDA Class 2 ·General Hospital

MULTIPLE PHARMA-PLAST TRACHEAL TUBE

FDA 510(k)

FDA Class 2 ·Anesthesiology

SupaChair Powered Wheelchair

FDA 510(k)

FDA Class 2 ·Physical Medicine

SupaChair Powered Wheelchair: COMBI 18, COMBI 18SP, COMBI 20, COMBI 20SP

FDA 510(k)

FDA Class 2 ·Physical Medicine

Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable Syringe with safety needle

FDA 510(k)

FDA Class 2 ·General Hospital

MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment; Temporary Cylinder; Comfort Cap; Healing Cap; Healing Cap Screw; Milling Abutment; EZ Post Abutment; Extra EZ Post Abutment; EZ Post Cylinder; ZrGEN Abutment; Multi-unit Abutment; Multi-unit Angled Abutment; AXA Abutment (Straight); AXA Abutment (Angled); Abutment Screw; Cylinder Screw; Crown Screw

FDA 510(k)

FDA Class 2 ·Dental

HemosIL Liquid Anti-Xa

FDA 510(k)

FDA Class 2 ·Hematology