Manual Antimicrobial Susceptibility Test Systems

FDA Pre-Market Approval

FDA Class 2 ·UNISCEPT(TM)

Manual Antimicrobial Susceptibility Test Systems

FDA Pre-Market Approval

FDA Class 2 ·UNISCEPT(TM)

HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE

FDA 510(k)

FDA Class 2 ·Microbiology

SCEPTOR - NEW ANTIMICROBIAL AGENT: CEFACLOR

FDA 510(k)

FDA Class 2 ·Microbiology

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

DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS

FDA 510(k)

FDA Class 2 ·Microbiology

The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL.

FDA 510(k)

FDA Class 2 ·Microbiology

ETEST SUBMISSION FOR AZITHROMYCIN/S. PNEUMONIAE

FDA 510(k)

FDA Class 2 ·Microbiology

ETEST CHLORAMPHENICAL

FDA 510(k)

FDA Class 2 ·Microbiology

SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE(HP) SUSCEPTIBILITY PLATES

FDA 510(k)

FDA Class 2 ·Microbiology

MICRO-MEDIA MICRODILUTION TEST PANELS

FDA 510(k)

FDA Class 2 ·Microbiology

MTS Doxycycline 0.016 - 256 µg/mL

FDA 510(k)

FDA Class 2 ·Microbiology

ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL

FDA 510(k)

FDA Class 2 ·Microbiology

NEW ANTIMICRO. AGENTS:AUGMENTIN,AZTREONAM,CIPROFLO

FDA 510(k)

FDA Class 2 ·Microbiology

Sensititre Susceptibility Plates

FDA 510(k)

FDA Class 2 ·Microbiology

DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH PENICILLIN

FDA 510(k)

FDA Class 2 ·Microbiology

SENSITIVE HAEMOPHILUS INFLUENZAE, STREPTOCOCCUS PNEUMONIA, (HP) MIC SUSCEPTIBILITY PLATES

FDA 510(k)

FDA Class 2 ·Microbiology

PASCO MIC AND MIC/ID PANELS, VANCOMYCIN

FDA 510(k)

FDA Class 2 ·Microbiology

The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with penicillin in the dilution range of 0.015-32 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