XPERT FLU

FDA 510(k)

FDA Class 2 ·Microbiology

XPERT MRSA/SA BLOOD CULTURE ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

XPERT CT/NG

FDA 510(k)

FDA Class 2 ·Microbiology

HERO

FDA 510(k)

FDA Class 2 ·Cardiovascular

ANEUVYSION MULITICOLOR DNA PROBE KIT

FDA 510(k)

FDA Class 2 ·Immunology

XPERT HEMOSIL FACTOR II & FACTOR V ASSAY

FDA 510(k)

FDA Class 2 ·Hematology

ABUSCREEN(R) ONLINE(TM) FOR BARBITURATES

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

AGGLUTEX BARBITURATES TEST KIT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ABUSCREEN RADIOIMMUNOASSAY-BARBITURATE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ABUSCREEN(R) ONTRAK(TM) FOR BARBITURATES

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DIGITAL PRINTER P6000D SERIES, MODEL P6000DU

FDA 510(k)

FDA Class 2 ·Radiology

Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5

FDA 510(k)

FDA Class 2 ·Radiology

DYNA IMPLANT DESIGN

FDA 510(k)

FDA Class 2 ·Dental

XPERT MRSA/SA BC (BLOOD CULTURE) ASSAY MODEL GXMRSA/SA-BC-10

FDA 510(k)

FDA Class 2 ·Microbiology

XPERT EV, MODEL GXEV-100N-10; GENEXPERT DX SYSTEM, MODELS P/N 900-0144, 900-0145, 900-0146, 900-0065

FDA 510(k)

FDA Class 2 ·Microbiology

DIASTAT ANTI-SM/RNP

FDA 510(k)

FDA Class 2 ·Immunology

DIASTAT ANTI-LA (SS-B)

FDA 510(k)

FDA Class 2 ·Immunology

DIASTAT ANTI-RO (SS-A)

FDA 510(k)

FDA Class 2 ·Immunology

DIASTAT ANTI-SM

FDA 510(k)

FDA Class 2 ·Immunology

DIASTAT ENA PROFILE

FDA 510(k)

FDA Class 2 ·Immunology