VIRAMED BIOTECH AG BORRELIA B31 IGG VIRASTRIPE, MODEL V-BBSGUS

FDA 510(k)

FDA Class 2 ·Microbiology

Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit

FDA 510(k)

FDA Class 2 ·Microbiology

DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

LIMITED HUMAN LYME IGG WESTERN BLOT KIT (CAMBRIDGE DIAGNOSTICS IRELAND)

FDA 510(k)

FDA Class 2 ·Microbiology

HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE NK001.T

FDA 510(k)

FDA Class 2 ·Immunology

Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit

FDA 510(k)

FDA Class 2 ·Microbiology

VARELISA B2 GLYCOPROTEIN I IGG ANTIBODIES, MODELS 18748 AND 18796

FDA 510(k)

FDA Class 2 ·Immunology

HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.T

FDA 510(k)

FDA Class 2 ·Immunology

IMMULISA ENHANCED CELIAC FUSION (TTG/DGP) IGA/IGG ANTIBODY ELISA

FDA 510(k)

FDA Class 2 ·Immunology

ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ARCHITECT ANTI-HCV ASSAY; ARCHITECT ANTI-HCV CALIBRATOR; ARCHITECT ANTI-HCV CONTROL

ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MPO/PR3 IGG TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

MODIFICATION TO: REAADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

THE APTUS (AUTOMATED) APPLICATION OF THE VZV IGG ELISA TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology

LIAISON BORRELIA IGG/IGM ASSAY, MODEL 310870; SERUM CONTROLS, MODEL 310871

FDA 510(k)

FDA Class 2 ·Microbiology

ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE TPO/TG IGG TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

HUMAN IGG SUBCLASS KIT FOR USE ON THE BECKMAN IMMAGE ANALYSER

FDA 510(k)

FDA Class 2 ·Immunology

IMMULITE RUBELLA QUANTITATIVE IGG, CATALOG # LKRBQ1 (100 TESTS), LKRBQ5 (500 TESTS)

FDA 510(k)

FDA Class 2 ·Microbiology

REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUANTITATIVE TEST KIT, MODEL 11139

FDA 510(k)

FDA Class 2 ·Immunology

EUROIMMUN ANCA IFA GRANULOCYTE BIOCHIP MOSCAIC IGG ANTIBODY IN HUMAN SERUM

FDA 510(k)

FDA Class 2 ·Immunology