OPUS PSA TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV

FDA 510(k)

FDA Class 2 ·Microbiology

ADVANTAGE CHEMILUMINESCENCE PROSTATE SPECIFIC ANTIGEN (PSA) IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Immunology

VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428

FDA 510(k)

FDA Class 2 ·Immunology

TOTAL PSA MICROTITER ELISA

FDA 510(k)

FDA Class 2 ·Immunology

SeraQuest HSV Type 2 Specific IgG

FDA 510(k)

FDA Class 2 ·Microbiology

PLEXUS HERPESELECT 1 AND 2 IGG (WITH PLEXUS TM SOFTWARE), MODEL MP0900G

FDA 510(k)

FDA Class 2 ·Microbiology

SeraQuest Herpes Type 1 Specific IgG

FDA 510(k)

FDA Class 2 ·Microbiology

BAYER PSA ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

BIOPLEX 2200 HSV-1 AND HSV-2 IGG ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology

ACTIVE PSA ELISA (DSL-10-9700)

FDA 510(k)

FDA Class 2 ·Immunology

ZEUS ELISA HSV GC-I IGG TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology

THE COMPLEXED PSA ASSAY FOR THE BAYER IMMUNO 1 SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

BIOCIRCUITS IOS PROSTATE SPECIFIC ANTIGEN (PSA) TEST CARTRIDGES, BIOCIRCUITS IOS PSA CONTROLS

FDA 510(k)

FDA Class 2 ·Immunology

COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

RapidFor™ Malaria P.f. / P.v. Rapid Test Kit (FIA)

Device

EU IVDD · Eu Ivd General ·Vitrosens Biyoteknoloji Anonim Şirketi·On the market

RapidFor™ HSV-2 IgG/IgM Rapid Test Kit

Device

EU IVDD · Eu Ivd General ·Vitrosens Biyoteknoloji Anonim Şirketi·On the market

RapidFor™ HSV-1 IgG/IgM Rapid Test Kit

Device

EU IVDD · Eu Ivd General ·Vitrosens Biyoteknoloji Anonim Şirketi·On the market

HSV 12 Antigen Rapid Test Kit (Colloidal gold method)

Device

EU IVDD · Eu Ivd General ·Nanjing Synthgene Medical Technology Co., Ltd. ·On the market

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

FDA Pre-Market Approval

FDA Class 3 ·ADVIA Centaur PSA, ADVIA Centaur CP PSA and Atellica IM PSA