TROJAN EXTRA LARGE LATEX CONDOM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MONO-LATEX (TM) SLIDE TEST

FDA 510(k)

FDA Class 2 ·Immunology

VIROGEN RUBELLA SLIDE TEST

FDA 510(k)

FDA Class 2 ·Microbiology

TBD AT-HOME PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BACTIGEN(R) H. INFLUENZAE TYPE B

FDA 510(k)

FDA Class 2 ·Microbiology

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

FDA 510(k)

FDA Class 2 ·Medical Genetics

Quantidex qPCR BCR-ABL IS Kit

FDA 510(k)

FDA Class 2 ·Medical Genetics

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

FDA 510(k)

FDA Class 2 ·Medical Genetics

BCR-ABL1 (p210) % IS Kit (Digital PCR Method)

FDA 510(k)

FDA Class 2 ·Medical Genetics

MRDx BCR-ABL Test, MRDx BCR-ABL Test Software

FDA 510(k)

FDA Class 2 ·Medical Genetics

Alere Afinion HbA1c and ACR on Afinion 2 analyzer

FDA 510(k)

FDA Class 2 ·Hematology

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·BREAST COMPANION SOFTWARE SYSTEM

ASSERACHROM PF4 KIT

FDA 510(k)

FDA Class 2 ·Hematology

VivoSight Dx Topical OCT System

FDA 510(k)

FDA Class 2 ·Radiology

OPTIS Metallic Stent Optimization E.4 SW

FDA 510(k)

FDA Class 2 ·Radiology

OPXION Optical Skin Viewer (OPXSV1-01F)

FDA 510(k)

FDA Class 2 ·Radiology

Ilumien Optis, Optis Integrated, Optis Mobile

FDA 510(k)

FDA Class 2 ·Radiology

Starlight Imaging Catheter

FDA 510(k)

FDA Class 2 ·Radiology

OTIS Optical Coherence Tomography System

FDA 510(k)

FDA Class 2 ·Radiology

Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2)

FDA 510(k)

FDA Class 2 ·Radiology