DIMENSION VISTA SYSTEM ENZYME 5 CALIBRATOR, MODEL KC350

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Emit II Plus Oxycodone Assay

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Emit II Plus Buprenorphine Assay, Emit II Plus Specialty Drug Calibrator/Control Level 1, Level 2 Level 3, Level 4, Emit II Plus Specialty Drug Control Negative, Emit II Plus Specialty Drug Control Positive

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

AMPHETAMINE/METHAMPHETAMINE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DIMENSION CREATININE (CRE2) FLEX REAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

INNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLS

FDA 510(k)

FDA Class 2 ·Hematology

INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5

FDA 510(k)

FDA Class 2 ·Hematology

COCAINE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

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

FDA 510(k)

FDA Class 2 ·Microbiology

ANTHRACIS 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, 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/H5 Subtyping Kit

FDA 510(k)

FDA Class 2 ·Microbiology

ECLIPSE 6.5

FDA 510(k)

FDA Class 2 ·Radiology

Variola virus Real-Time PCR Assay

FDA 510(k)

FDA Class 2 ·Microbiology

DIMENSION CSAE CYCLOSPORINE EXTENDED RANGE CALIBRATOR, MODEL DC108

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

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