QUANTA LITE GPA (GASTRIC PARIETAL CELL ANTIBODY) ELISA

FDA 510(k)

FDA Class 2 ·Immunology

SeraQuest Herpes Type 1 Specific IgG

FDA 510(k)

FDA Class 2 ·Microbiology

FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

DRIED GRAM-POSITIVE MIC/COMBO PANELS

FDA 510(k)

FDA Class 2 ·Microbiology

MUELLER HINTON CHOCOLATE AGAR

FDA 510(k)

FDA Class 2 ·Microbiology

SM EIA DIAGNOSTIC KIT

FDA 510(k)

FDA Class 2 ·Immunology

Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls

FDA 510(k)

FDA Class 2 ·Immunology

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-VANCOMYCIN GRAM POSITIVE

FDA 510(k)

FDA Class 2 ·Microbiology

FREELITE HUMAN KAPPA AND LAMBDA KITS

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA PLEX ENA PROFILE 4

FDA 510(k)

FDA Class 2 ·Immunology

MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012

FDA 510(k)

FDA Class 2 ·Microbiology

VIDAS CA 125 II ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUS

FDA 510(k)

FDA Class 2 ·Immunology

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PHOENIX INDUCIBLE MACROLIDE RESISTANCE TEST

FDA 510(k)

FDA Class 2 ·Microbiology

STOCK ANTIMICROBIC SOLUTIONS

FDA 510(k)

FDA Class 2 ·Microbiology

THYROID PEROXIDASE AUTO ANTIBODIES(TPO) IMMUN KIT

FDA 510(k)

FDA Class 2 ·Immunology

PROSPECT CRYPTOSPORIDIUM RAPID ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

BD MAX Extended Enteric Bacterial Panel, BD MAX System

FDA 510(k)

FDA Class 2 ·Microbiology

ACS:CENTAUR AFP

FDA 510(k)

FDA Class 2 ·Immunology

F/LS MCA APPLICATION SOFTWARE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry