NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

STAT PROFILE ULTRA 11 ANALYZER (MODIFICATION)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

IMMULITE 2000 CARCINOEMBRYONIC ANTIGEN (CEA) KIT

FDA 510(k)

FDA Class 2 ·Immunology

STAT PROFILE PHOX ANALYZER

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

IMMULITE 2000 SPECIFIC ALLERGENS

FDA 510(k)

FDA Class 2 ·Immunology

STAT PROFILE PHOX CO-OXIMETER ANALYZER, NOVA CO-OXIMETER CONTROLS, LEVELS 1 AND 2, NOVA CO-OXIMETER THB CALIBRATOR

FDA 510(k)

FDA Class 2 ·Hematology

CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit,

FDA 510(k)

FDA Class 2 ·Microbiology

CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit

FDA 510(k)

FDA Class 2 ·Microbiology

ANTHRACIS REAL-TIME PCR ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

Variola virus Real-Time PCR Assay

FDA 510(k)

FDA Class 2 ·Microbiology

CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, INFLUENZA A/B TYPING KIT

FDA 510(k)

FDA Class 2 ·Microbiology

Rickettsia Real-time PCR Assay

FDA 510(k)

FDA Class 2 ·Microbiology

CDC Human Influenza Virus Real- time RT-PCR Diagnostic Panel, Influenza A/H5 Subtyping

FDA 510(k)

FDA Class 2 ·Microbiology

Integrity V500 (Integrity, Integrity with VEMP)

FDA 510(k)

FDA Class 2 ·Neurology

VIVOSONIC NEUROSCREEN

FDA 510(k)

FDA Class 2 ·Neurology

SAM CRRT Unit, SAM Cassette CRRT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Endotoxin Activity Assay (EAA)

FDA 510(k)

FDA Class 2 ·Microbiology

SPECTRAL WEST NILE VIRUS IGM STATUS TEST

FDA 510(k)

FDA Class 2 ·Microbiology

ProCell Surgical Sponge-Blood Recovery Unit

FDA 510(k)

FDA Class 2 ·Anesthesiology

BI-FLEX URETERAL ACCESS SHEATH

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology