MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN/SULBACTAM (0.5/0.25-64/34 UG/ML)

FDA 510(k)

FDA Class 2 ·Microbiology

MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TRIMETHOPRIM/SULFAMETHOXAZOLE (0.25/4.75-64/1216 UG/ML)

FDA 510(k)

FDA Class 2 ·Microbiology

Sensititre 18-24 hours MIC or BP Susceptibility System with Ceftolozane/tazobactam (0.03/4- 64/4ug/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

MODIFICATION TO PROMAX-XP, TENS AND MICROCURRENT DEVICE; PROMAX-TENS, TENS DEVICE; PROMAX-LIBRA, TENS DEVICE; PROMAX-MIC

FDA 510(k)

FDA Class 2 ·Neurology

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

SIEMENS PC AUIDIOMETER MODEL SD 100 & PC PROBE MIC SYSTEM MODEL SD 110/SD WITH UNITY SOPFTWARE SUITE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.03-32ug/ml

FDA 510(k)

FDA Class 2 ·Microbiology

Sensititre 18-24 hour MIC Breakpoint Susceptibility System with Plazomicin in the dilution range of 0.06-128 ug/mL

FDA 510(k)

FDA Class 2 ·Microbiology

Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 ug/ml

FDA 510(k)

FDA Class 2 ·Microbiology

Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.004-8 ug/mL

FDA 510(k)

FDA Class 2 ·Microbiology

Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 µg/ml

FDA 510(k)

FDA Class 2 ·Microbiology

Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Eravacycline in the dilution range of 0.008- 16 µg/mL

FDA 510(k)

FDA Class 2 ·Microbiology

Implant, Muscle, Pectoralis

FDA classification

FDA Class 2 ·Implant, Muscle, Pectoralis

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL

FDA 510(k)

FDA Class 2 ·Microbiology

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.25-32 ug/mL

FDA 510(k)

FDA Class 2 ·Microbiology

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mL

FDA 510(k)

FDA Class 2 ·Microbiology

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the dilution range of 0.25-128 ug/mL

FDA 510(k)

FDA Class 2 ·Microbiology

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Daptomycin in the dilution range of 0.03-64 ug/mL

FDA 510(k)

FDA Class 2 ·Microbiology

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.0005 – 8 ug/mL

FDA 510(k)

FDA Class 2 ·Microbiology

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Moxifloxacin in the dilution range of 0.008-16 ug/mL

FDA 510(k)

FDA Class 2 ·Microbiology