HERPESELECT EXPRESS IGG, HERPESELECT EXPRESS CONTROLS, MODELS RT0920G, RT0950

FDA 510(k)

FDA Class 2 ·Microbiology

SeraQuest HSV Type 2 Specific IgG

FDA 510(k)

FDA Class 2 ·Microbiology

ATHENA MULTI-LYTE HSV 1 & 2 IGG TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology

HERPES SIMPLEX VIRUS TYPE 1 IGG ELISA TEST

FDA 510(k)

FDA Class 2 ·Microbiology

LIAISON HSV-1 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-1 IGG

FDA 510(k)

FDA Class 2 ·Microbiology

HERPESELECT 2 ELISA IGG, MODEL ELO920G

FDA 510(k)

FDA Class 2 ·Microbiology

ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls

FDA 510(k)

FDA Class 2 ·Microbiology

ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV

FDA 510(k)

FDA Class 2 ·Microbiology

SeraQuest HSV Type 2 Specific IgG

FDA 510(k)

FDA Class 2 ·Microbiology

PLEXUS HERPESELECT 1 AND 2 IGG (WITH PLEXUS TM SOFTWARE), MODEL MP0900G

FDA 510(k)

FDA Class 2 ·Microbiology

SeraQuest Herpes Type 1 Specific IgG

FDA 510(k)

FDA Class 2 ·Microbiology

BIOPLEX 2200 HSV-1 AND HSV-2 IGG ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology

ZEUS ELISA HSV GC-I IGG TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ARCHITECT ANTI-HCV

CURIEPACS (DICOM PACS SOFTWARE)

FDA 510(k)

FDA Class 2 ·Radiology

LumenEye® X1 endoscope (LX1-SCP-203); LumenEye® X1 consumables (LX1-CSB-201); LumenEye® X1 Consumable Carton (25 Sets) (LX1-CSP-201 )

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ASTOFLO

FDA 510(k)

FDA Class 2 ·Hematology

BIOZ DX HEMODYNAMIC MONITOR WITH PHILIPS 12-LEAD ECG, MODEL 5100

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARDIODYNAMICS BIOZ RX, MODEL 7101-SYS

FDA 510(k)

FDA Class 2 ·Cardiovascular

AESCULON C2, AESCULON CHF CLINIC C2, AESCULON HYPERTENSION CLINIC C2 AND AESCULON PACEMAKER CLINIC C2

FDA 510(k)

FDA Class 2 ·Cardiovascular