N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM) AND N/T PROTEIN CONTROL LC

FDA 510(k)

FDA Class 2 ·Immunology

Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4, DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ETHANOL

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DIMENSION VISTA ETOH FLEX REAGENT CARTRIDGE, MODEL K5022

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CREATININE KINASE MB ISOENZYME VERIFIER, MODEL DC27

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Monitor, Apnea, Home Use

FDA classification

FDA Class 2 ·Monitor, Apnea, Home Use

CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/HS Subtyping Kit

FDA 510(k)

FDA Class 2 ·Microbiology

INFLUENZA A/H5 (ASIAN LINEAGE) VIRUS REAL-TIME RT-PCR PRIMER AND PROBE SET

FDA 510(k)

FDA Class 2 ·Microbiology

DIMENSION VISTA CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

RPM RESPIRATORY GATING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes and Length Assessment Device

FDA 510(k)

FDA Class 2 ·Radiology

Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set

FDA 510(k)

FDA Class 2 ·Microbiology

PROTON VISION 7.0

FDA 510(k)

FDA Class 2 ·Radiology

TRILOGY WITH EXTERNAL SYSTEM GATING INTERFACE

FDA 510(k)

FDA Class 2 ·Radiology

4D INTEGRATED TREATMENT CONSOLE WITH PATIENT ACCESSORY VERIFICATION SYSTEM (PAVS)

FDA 510(k)

FDA Class 2 ·Radiology

Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set

FDA 510(k)

FDA Class 2 ·Microbiology

PORTALVISION ADVANCED IMAGING

FDA 510(k)

FDA Class 2 ·Radiology

TRILOGY SYSTEM WITH RAPIDARC

FDA 510(k)

FDA Class 2 ·Radiology