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

BD BBL Sensi-Disc Ceftazidime Avibactam (30/20ug), Antimicrobial Susceptibility Test Disks

FDA 510(k)

FDA Class 2 ·Microbiology

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

Valkyrie Thoracic Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

BOOMERANG ABSORPTION COMENSATION FILTER

FDA 510(k)

FDA Class 2 ·Radiology

Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems

FDA 510(k)

FDA Class 2 ·Medical Genetics

LED Light Therapy Mask (G15, G15P, G15K, G11P, G11, G10, G13, G14, G17, VISO, PRANA, Chin2Chest, BBL-FACEMASK)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control

FDA classification

FDA Class 2 ·Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control

Infant Supine Sleep System

FDA classification

FDA Class 2 ·Infant Supine Sleep System

Control Material, Blood Circulating Epithelial Cancer Cell

FDA classification

FDA Class 2 ·Control Material, Blood Circulating Epithelial Cancer Cell

Transducer, Ultrasonic, Obstetric

FDA Pre-Market Approval

FDA Class 2 ·TENNANT(TM) & KELMAN(TM) TYPE II

Transducer, Ultrasonic, Obstetric

FDA Pre-Market Approval

FDA Class 2 ·TENNANT(TM) & KELMAN(TM) TYPE II

Transducer, Ultrasonic, Obstetric

FDA Pre-Market Approval

FDA Class 2 ·YENNANT(TM) & KELMAN(TM) TYPE II

Transducer, Ultrasonic, Obstetric

FDA Pre-Market Approval

FDA Class 2 ·TENNANT(TM) & KELMAN(TM) TYPE II