BD VIPER LT SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FilmArray Warrior Control Panel M290

FDA 510(k)

FDA Class 2 ·Microbiology

CEFEPINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

FDA 510(k)

FDA Class 2 ·Microbiology

CANDIDA DETECTION SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology

Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mL

FDA 510(k)

FDA Class 2 ·Microbiology

SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH GENTAMICIN (0.06-32MG/ML LONG DILUTION SEQUENCE

FDA 510(k)

FDA Class 2 ·Microbiology

URINE DUO

FDA 510(k)

FDA Class 2 ·Microbiology

QUANTA LITE LYME IGG ELISA

FDA 510(k)

FDA Class 2 ·Microbiology

TREND GIARDIA DIRECT DETECTION RS TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology

BRUCELLA IFA*

FDA 510(k)

FDA Class 2 ·Microbiology

SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738)

FDA 510(k)

FDA Class 2 ·Microbiology

ARCHITECT HAVAB-G

FDA 510(k)

FDA Class 2 ·Microbiology

Sensititre 18-24 Hour MIC or Breakpoint Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/ml

FDA 510(k)

FDA Class 2 ·Microbiology

BD DIRECTIGEN EZ FLU A + B

FDA 510(k)

FDA Class 2 ·Microbiology

HARDYDISK RIFAMPIN, 5MCG

FDA 510(k)

FDA Class 2 ·Microbiology

MODIFICATION TO: RAMP INFLUENZA A/B ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

LIAISON VZV IgG HT, LIAISON Control VZV IgG HT

FDA 510(k)

FDA Class 2 ·Microbiology

GEN-PROBE PACE SYSTEM FOR NEISSERIA GONORRHOEAE

FDA 510(k)

FDA Class 2 ·Microbiology

HARDYDISK, CARBENICILLIN, 100MCG

FDA 510(k)

FDA Class 2 ·Microbiology

Acuitas AMR Gene Panel

FDA 510(k)

FDA Class 2 ·Microbiology