MUELLER HINTON AGAR

FDA 510(k)

FDA Class 2 ·Microbiology

API UNISCEPT(R) MICRO-MIC(R) SYSTEM/UNISCEPT MIC

FDA 510(k)

FDA Class 2 ·Microbiology

MODIFIED FOX EXTRA GRAM POSITIVE

FDA 510(k)

FDA Class 2 ·Microbiology

SENSITITRE 18-24 HOUR SUSECEPTIBILITY PLATES

FDA 510(k)

FDA Class 2 ·Microbiology

MODIFICATION TO SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE

FDA 510(k)

FDA Class 2 ·Microbiology

MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 µg/mL

FDA 510(k)

FDA Class 2 ·Microbiology

SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES

FDA 510(k)

FDA Class 2 ·Microbiology

CULTURE AND SENSITIVITY KIT

FDA 510(k)

FDA Class 2 ·Microbiology

Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Dalbavancin (0.0005 - 2ug/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

MTS Lefamulin 0.016- 256 µg/mL

FDA 510(k)

FDA Class 2 ·Microbiology

ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

Liofilchem MIC Test Strip (MTS), Azithromycin 0.016 - 256 µg/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

HAEMOPHILUS/PNEUMOCOCCUS MIC PLATE

FDA 510(k)

FDA Class 2 ·Microbiology

GRAM POSITIVE DRIED OVERNIGHT PANELS/LOMEFLOX

FDA 510(k)

FDA Class 2 ·Microbiology

ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL (IMIPENEM)

FDA 510(k)

FDA Class 2 ·Microbiology

ETEST SUBMISSION FOR VANCOMYCIN

FDA 510(k)

FDA Class 2 ·Microbiology

SCEPTOR STAPHYLOCOCCUS MIC/ID PANEL #80325

FDA 510(k)

FDA Class 2 ·Microbiology

SCEPTOR-NEW ANTIMICROBIAL AGENT:TICAR/CLAVU ACID

FDA 510(k)

FDA Class 2 ·Microbiology

SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE

FDA 510(k)

FDA Class 2 ·Microbiology