D-DI TEST KIT

FDA 510(k)

FDA Class 2 ·Hematology

XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B

FDA 510(k)

FDA Class 1 ·Microbiology

FIBRIN(OGEN) DEGRADATION PRODUCTS(FDP)

FDA 510(k)

FDA Class 2 ·Hematology

MODIFICATION TO TINA-QUANT D-DIMER TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology

MDA D-DIMER

FDA 510(k)

FDA Class 2 ·Hematology

FDP ASSAY-20 TEST KIT

FDA 510(k)

FDA Class 2 ·Hematology

AGEN DIMERTEST GOLD EIA

FDA 510(k)

FDA Class 2 ·Hematology

FIBRINOSTICON

FDA 510(k)

FDA Class 2 ·Hematology

PATHFAST D-DIMER

FDA 510(k)

FDA Class 2 ·Hematology

PRIMA SYSTEM - OLD, BARTELS ELISA - NEW

FDA 510(k)

FDA Class 1 ·Microbiology

MODIFIED D-DI-TEST KIT

FDA 510(k)

FDA Class 2 ·Hematology

PROSPECT MICROPLATE ASSAY

FDA 510(k)

FDA Class 1 ·Microbiology

IMMUNOCARD TOXINS A & B, MODEL 712050

FDA 510(k)

FDA Class 1 ·Microbiology

DIMERTEST LATEX

FDA 510(k)

FDA Class 2 ·Hematology

DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET

FDA 510(k)

FDA Class 2 ·Hematology

SensiTox C. difficile Toxin Test

FDA 510(k)

FDA Class 1 ·Microbiology

ADVIA Centaur CA 15-3 assay

FDA 510(k)

FDA Class 2 ·Immunology

ARCHITECT CA 15-3 ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

ELECSYSCA 15-3 II ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

ACS 180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM)

FDA 510(k)

FDA Class 2 ·Immunology