Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT TOTAL PSA

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT HBSAG QUALITATIVE/CONFIRMATORY

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT CORE-M

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT HBSAG/CONFIRMATORY

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT AUSAB

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT ARCHITECT FREE PSA

ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

THE APTUS (AUTOMATED) APPLICATIONS OF THE DS DNA ELISA TEST SYSTEM LINKED IMMUNOSORBENT ASSAY(ELISA)FOR THE DET

FDA 510(k)

FDA Class 2 ·Immunology

ANTI-DSDNA KIT, IM.77/771 (50/100 TEST KITS)

FDA 510(k)

FDA Class 2 ·Immunology

IMMULISA DSDNA ANTIBODY ELISA

FDA 510(k)

FDA Class 2 ·Immunology

HYCOR HY.TEC/MANUAL DS-DNA AUTO-ANTIBODY

FDA 510(k)

FDA Class 2 ·Immunology

FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KIT

FDA 510(k)

FDA Class 2 ·Immunology

HYTEC AUTOMIMMUNE KIT (DS-DNA)

FDA 510(k)

FDA Class 2 ·Immunology

ENCORE DS-DNA

FDA 510(k)

FDA Class 2 ·Immunology

IMMUSTRIP(TM) DSDNA ELISA TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05)

FDA 510(k)

FDA Class 2 ·Hematology

IS-DSDNA TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

DSDNA IMMUNOGLOBULIN EIA TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

NDNA ANTIBODY TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

VARELISA COMBINED DNA ANTIBODIES EIA

FDA 510(k)

FDA Class 2 ·Immunology