Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ADVIA Centaur and Atellica IM HCV

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ARCHTECT ANTI-HCV

CALTAG CD8 FITC AND CD8 R-PE MONOCLONAL ANTIBODIES

FDA 510(k)

FDA Class 2 ·Hematology

BC-3200 AUTO HEMATOLOGY ANALYZER

FDA 510(k)

FDA Class 2 ·Hematology

Cito CBC System

FDA 510(k)

FDA Class 2 ·Hematology

FLOW-COUNT COULTER FLUOROSPHERES

FDA 510(k)

FDA Class 2 ·Hematology

CD2 MONOCLONAL ANTIBODIES

FDA 510(k)

FDA Class 2 ·Hematology

CELL-DYN 3000 MULTI-PARAMETER HEMATOLOGY ANALYER

FDA 510(k)

FDA Class 2 ·Hematology

CELL-DYN RUBY SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology

RPR CARD TEST KIT

FDA 510(k)

FDA Class 2 ·Microbiology

STANBIO SYPHILIS RPR TEST, NO. 1170

FDA 510(k)

FDA Class 2 ·Microbiology

HEMATRAK MODEL 125

FDA 510(k)

FDA Class 2 ·Hematology

COULTER AC T DIFF 2 ANALYZER

FDA 510(k)

FDA Class 2 ·Hematology

AVANTI POLAR LIPIDS VDRL ANTIGEN SLIDE TEST KIT WITH 10 X 0.5 ML AMPULES, AVANTI POLAR LIPIDS BULK BDRL ANTIGEN, AVANTI

FDA 510(k)

FDA Class 2 ·Microbiology

CELL DYN 3500 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER (MODIFICATION)

FDA 510(k)

FDA Class 2 ·Hematology

TECHNICON H*1 SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology

SYSMEX XT-SERIES, MODEL XT-2000I AND XT-1800I

FDA 510(k)

FDA Class 2 ·Hematology

MODIFICATION OF: CELL-DYN 1200 SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology

CELLEXIS HEMATOLOGY ANALYZER

FDA 510(k)

FDA Class 2 ·Hematology

BD FACSCANTO II FLOW CYTOMETER, MODEL 338960; (5-3), MODEL 339473; (4-2-2), MODEL 338962

FDA 510(k)

FDA Class 2 ·Hematology