ANTI-GBM ANTIBODIES QUANTITATIVE KIT

FDA 510(k)

FDA Class 2 ·Immunology

MOUSE LIVER KIDNEY STOMACH DIAGNOSTIC TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

KALLESTAD FLORESCENT ANA/AMA/ASMA TEST

FDA 510(k)

FDA Class 2 ·Immunology

EIA KIT FOR THE DETECTION OF GBM ANTIBODIES

FDA 510(k)

FDA Class 2 ·Immunology

I-125 ANTI-MICROSOMAL ANTIBODY IRMA TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT

FDA 510(k)

FDA Class 2 ·Immunology

ANTI-SKIN ANTIBODY TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

NOVA LITE ENDOMYSIAL

FDA 510(k)

FDA Class 2 ·Immunology

ANTINUCLEAR ANTIBODY SCREEN FLOURESC

FDA 510(k)

FDA Class 2 ·Immunology

ANTI-NUCLEAR ANTIBODY(ANA) TEST KIT W/MOUSE LIVER

FDA 510(k)

FDA Class 2 ·Immunology

ANTI-ENDOMYSIAL ANTIBODY TEST

FDA 510(k)

FDA Class 2 ·Immunology

4CIS SARA SPINE SYSTEM, 4CIS VERTU SPINE SYSTEM, 4CIS WILL PEDICLE SCREW SYSTEM, aBle SPINAL FIXATION SYSTEM, aBle Xt SPINAL FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Graft, Vascular, Synthetic/Biologic Composite

FDA Pre-Market Approval

FDA Class 2 ·VASCUTEK GELSOFT(TM) VASCULAR GRAFT

Graft, Vascular, Synthetic/Biologic Composite

FDA Pre-Market Approval

FDA Class 2 ·VASCUTEK GELSOFT(TM) VASCULAR GRAFT

Graft, Vascular, Synthetic/Biologic Composite

FDA Pre-Market Approval

FDA Class 2 ·VASCUTEK GELSEAL(TM) VASCULAR GRAFT

Graft, Vascular, Synthetic/Biologic Composite

FDA Pre-Market Approval

FDA Class 2 ·VASCUTEK GELSEAL(TM) VASCULAR GRAFT

Graft, Vascular, Synthetic/Biologic Composite

FDA Pre-Market Approval

FDA Class 2 ·GELSEAL TM TRIAXIAL VASCULAR GRAFT

Graft, Vascular, Synthetic/Biologic Composite

FDA Pre-Market Approval

FDA Class 2 ·ALBUMIN COATED DEBAKEY(R) VASCULAR(R) VASCULAR-II

QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System

FDA 510(k)

FDA Class 2 ·Medical Genetics

Valkyrie Thoracic Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic