MDA D-DIMER

FDA 510(k)

FDA Class 2 ·Hematology

VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4 µg/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 µg/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

VITEK 2 AST-YS FLUCONAZOLE

FDA 510(k)

FDA Class 2 ·Microbiology

VITEK 2 AST-Gram Positive Dalbavancin (<= 0.015 - >= 1 µg/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

NUCLISENS EASYQ ENTEROVIRUS V1.1., NUCLISENS EASYQ DIRECTOR 2.6, NUCLISENS EASYQ ANALYZER, NUCLISENS MINIMAG

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VIDAS D-DIMER EXCLUSION ASSAY, MODEL 30 442

FDA 510(k)

FDA Class 2 ·Hematology

VITEK 2 GRAM POSITIVE TIGECYCLINE

FDA 510(k)

FDA Class 2 ·Microbiology

VITEK 2 GRAM NEGATIVE TIGECYCLINE

FDA 510(k)

FDA Class 2 ·Microbiology

VIDAS NT-PROBNP ASSAY, MODEL: 30 449

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VITEK 2 AST - YEAST FLUCONAZOLE

FDA 510(k)

FDA Class 2 ·Microbiology

VITEK 2 STREPTOCOCCUS ERYTHROMYCIN

FDA 510(k)

FDA Class 2 ·Microbiology

VITEK GRAM NEGATIVE SUSCEPTIBILITY (GNS) CARD FOR MOXIFLOXACIN

FDA 510(k)

FDA Class 2 ·Microbiology

VITEK 2 GRAM POSITIVE MEROPENEM FOR STREPTOCOCCUS PNEUMONIAE

FDA 510(k)

FDA Class 2 ·Microbiology

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

FDA 510(k)

FDA Class 2 ·Immunology

VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin

FDA 510(k)

FDA Class 2 ·Microbiology

VITEK 2 AST- Gram Positive Telavancin (<=0.015 - >=1 µg/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

VITEK 2 STREPTOCOCCUS LEVOFLOXACIN

FDA 510(k)

FDA Class 2 ·Microbiology

chromID MRSA

FDA 510(k)

FDA Class 2 ·Microbiology