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

FDA Pre-Market Approval

FDA Class 3 ·Alinity i Anti-HBc lgM

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

FDA Pre-Market Approval

FDA Class 3 ·LIAISON® XL MUREX HBc lgM assay and Control

CALTAG CD8 FITC AND CD8 R-PE MONOCLONAL ANTIBODIES

FDA 510(k)

FDA Class 2 ·Hematology

CALTAG CD4 R-PE MONOCLONAL ANTIBODY

FDA 510(k)

FDA Class 2 ·Hematology

CD3 FITC/CD4 R-PE MONOCLONAL ANTIBODY COMBINATION

FDA 510(k)

FDA Class 2 ·Hematology

CD3 FITC/CD4 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION

FDA 510(k)

FDA Class 2 ·Hematology

CD3 FITC/CD8 R-PE MONOCLONAL ANTIBODY COMBINATION

FDA 510(k)

FDA Class 2 ·Hematology

CD3 TRI-COLOR/CD4 R-PE/CD8 FITC MONOCLONAL ANTIBODY COMBINATION

FDA 510(k)

FDA Class 2 ·Hematology

CD3 FITC/CD8 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION

FDA 510(k)

FDA Class 2 ·Hematology

CALTAG CD3 FITC, R-PE, TRI-COLOR MONOCLONAL ANTIBODY

FDA 510(k)

FDA Class 2 ·Hematology

DRI HEMOGLOBIN A1C ASSAY AND CALIBRATORS

FDA 510(k)

FDA Class 2 ·Hematology

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

FDA Pre-Market Approval

FDA Class 3 ·Atellica IM Hepatitis B core IgM (aHBcM) assay; Atellica IM Hepatitis B core lgM Quality Control (aHBcM QC)

SYNELISA SM ABS/RNP-SM ABS

FDA 510(k)

FDA Class 2 ·Immunology

THERATEST EL-ANA PROFILES

FDA 510(k)

FDA Class 2 ·Immunology

ENZYMATIC ACETAMINOPHEN ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

LIQUICHEK ANTI-SM CONTROL, EIA, MODEL 208

FDA 510(k)

FDA Class 2 ·Immunology

LIQUICHEK ANTI-SM CONTROL, POSITIVE, CATALOG #115

FDA 510(k)

FDA Class 2 ·Immunology

SERAQUEST ANTI-SM/RNP

FDA 510(k)

FDA Class 2 ·Immunology

VARELISA SM ANTIBODIES

FDA 510(k)

FDA Class 2 ·Immunology

EIA SMDP IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Immunology