Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ETI-MAK-2PLUS & ETI-MAK-2 PLUS HBSAG CONFIRMATORY TEST KIT

ANTI RNA POLYMERASE III ELISA KIT, MODEL 7805

FDA 510(k)

FDA Class 2 ·Immunology

DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

KEITH NASOGASTRIC SUMP TUBE W/ANTI-REFLUX VALVE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BINDAZYME ANTI B2 GP1 IGM EIA TEST KIT.

FDA 510(k)

FDA Class 2 ·Immunology

PHARMACIA DELTEC EXTENSION SET WITH ANTI-SIPHON VALVE

FDA 510(k)

FDA Class 2 ·General Hospital

IGG ANTI-GLIADIN (IGG-AGA) ANTIBODY TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

LIQUICHEK ANTI-SS-A CONTROL, POSITIVE, CATALOG #114

FDA 510(k)

FDA Class 2 ·Immunology

REAADS IGA ANTI-PHOSPHATIDYLSERINE SEMI-QUANTITATIVE TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

LIQUICHEK ANTI-SCL-70 CONTROL, EIA, MODEL 212

FDA 510(k)

FDA Class 2 ·Immunology

IMMULITE 2000 ANTI-TPO AB, MODEL L2KT02, L2KT06

FDA 510(k)

FDA Class 2 ·Immunology

LIQUICHEK ANTI-SS-B CONTROL, EIA, MODEL 210

FDA 510(k)

FDA Class 2 ·Immunology

LIQUICHEK ANTI-SMOOTH MUSCLE CONTROL, POSITIVE, CATALOG #129

FDA 510(k)

FDA Class 2 ·Immunology

IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGG ELISA

FDA 510(k)

FDA Class 2 ·Immunology

ZEUS SCIENTIFIC INC., ANTI-EBV EA IGG ELISA

FDA 510(k)

FDA Class 1 ·Microbiology

LIQUICHEK ANTI-SS-A CONTROL, EIA, MODEL 209

FDA 510(k)

FDA Class 2 ·Immunology

ONE WEEK BACKSTOP DENTAL ANTI-RETRACTION CHECK VALVE

FDA 510(k)

FDA Class 1 ·Dental

INDIRECT FLUORESCENT ASSAY FOR (EBV-VCA) IGG ANTI.

FDA 510(k)

FDA Class 1 ·Microbiology

DAKO RABBIT ANTI-COW S-100 POLYCLONAL ANTIBODY

FDA 510(k)

FDA Class 2 ·Immunology

ANTI-HERPES SIMPLEX VIRUS TYPE 1 OR 2

FDA 510(k)

FDA Class 2 ·Microbiology