XPERT HEMOSIL FACTOR II & FACTOR V ASSAY

FDA 510(k)

FDA Class 2 ·Hematology

Xpert® FII & FV

FDA 510(k)

FDA Class 2 ·Hematology

SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Deinition AS/AS+, SOMATOM Confidence

FDA 510(k)

FDA Class 2 ·Radiology

COLLAGRAFT STRIP BONE GRAFT MATRIX (FOR USE AS A BONE FILLER), MODEL 1X,3X,6X (1,3 OR 6 STRIPS PER BOX)

FDA 510(k)

FDA Class 2 ·Orthopedic

ACS:CENTAUR PSA2 IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Immunology

ELECSYS PSA, MODEL 2010

FDA 510(k)

FDA Class 2 ·Immunology

IMMULITE 2000 PSA

FDA 510(k)

FDA Class 2 ·Immunology

IMMULITE 2000 3RD GENERATION PSA

FDA 510(k)

FDA Class 2 ·Immunology

QUALISYS PSA IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Immunology

DIMENSION PSA FLEX REAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Immunology

ELECSYS PSA (ON ELECSYS 1010)

FDA 510(k)

FDA Class 2 ·Immunology

FREND PSA PLUS (reagent cartridge)

FDA 510(k)

FDA Class 2 ·Immunology

ENZYMUN-TEST PSA

FDA 510(k)

FDA Class 2 ·Immunology

VITROS IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK

FDA 510(k)

FDA Class 2 ·Immunology

FREND PSA PLUS (REAGENT CARTRIDGE)

FDA 510(k)

FDA Class 2 ·Immunology

ELECSYS PSA ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

IMMULITE THIRD GENERATION PSA (LKUPI,LKUP5)

FDA 510(k)

FDA Class 2 ·Immunology

INVADER MTHFR 1298

FDA 510(k)

FDA Class 2 ·Hematology

ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229

FDA 510(k)

FDA Class 2 ·Immunology