GEMSTAR SYSTEM

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

ENI ANTIBODY TO MEASLES(RUBEOLA) VIRUS

FDA 510(k)

FDA Class 1 ·Microbiology

GEMENI IGM ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

ENI ANTIBODY TO EPSTEIN-BARR VIRUS

FDA 510(k)

FDA Class 1 ·Microbiology

ANTIBODY TO VARICELLA-ZOSTER VIRUS

FDA 510(k)

FDA Class 2 ·Hematology

VIRGO REAGENTS INDIRECT FLUORSCENT

FDA 510(k)

FDA Class 2 ·Immunology

ANTIBODY TO HERPESVIRUS HOMINIS

FDA 510(k)

FDA Class 2 ·Microbiology

ANTIBODY TO RESPIRATORY SYNCYTIAL VIRUS

FDA 510(k)

FDA Class 1 ·Microbiology

GEMENI URIC ACID U.V.

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

DETECTION OF THEOPHYLLINE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

GEMSTAR IPA THEOPHYLLINE TEST KIT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

STARLYTE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VIRGO IMMUNO-PRECIPITATION ASSAY TOBRA

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DELTA TROL I & II

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

AMYLASE LTS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CHOLESTEROL (TOTAL) ANALYSIS PRODUCTS

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

RIAUSE AUTO PROCESSOR

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

VIRGO IPA FOR DETECTION OF PHENYTOIN

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

FLEXIGRAM AUTO LOADER SYSTEM

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

CREATINE KINASE REAGENT CK LTS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry