Colibrí System

FDA 510(k)

FDA Class 2 ·Microbiology

VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

VITEK 2 AST-Gram Negative Piperacillin / Tazobactam (<=4 - =>128 µg/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

VITEK 2 GRAM POSITIVE VANCOMYCIN

FDA 510(k)

FDA Class 2 ·Microbiology

VITEK 2 GRAM NEGATIVE PIPERACILLIN

FDA 510(k)

FDA Class 2 ·Microbiology

VITEK 2 STREPTOCOCCUS TRIMETHOPRIM/SULFAMETHOXAZOLE

FDA 510(k)

FDA Class 2 ·Microbiology

VITEK 2 GRAM POSITIVE GATIFLOXACIN

FDA 510(k)

FDA Class 2 ·Microbiology

VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 µg/mL), VITEK 2 Streptococcus Penicillin

FDA 510(k)

FDA Class 2 ·Microbiology

VITEK 2 AST STREPTOCOCUS VANCOMYCIN

FDA 510(k)

FDA Class 2 ·Microbiology

VITEK 2 AST-Gram Negative Meropenem/Vaborbactam (<=0.5/8 – >=64/8 µg/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

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

FDA 510(k)

FDA Class 2 ·Microbiology

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology

DENSICHECK PLUS

FDA 510(k)

FDA Class 2 ·Microbiology

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- CEFUROXIME GRAM NEGATIVE

FDA 510(k)

FDA Class 2 ·Microbiology

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN (STREP) 0.0625 - 8UG/ML

FDA 510(k)

FDA Class 2 ·Microbiology

MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANEL WITH SYNERCID (0.12-2UG/ML 5DILUTION BREAKPOINT SEQUENCE

FDA 510(k)

FDA Class 2 ·Microbiology

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM,-AMPICILLIN 0.5.-32 UG/ML

FDA 510(k)

FDA Class 2 ·Microbiology

VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

VITEK 2 AST-Yeast Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole

FDA 510(k)

FDA Class 2 ·Microbiology

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERYTHROMYCIN (STREP) 0.0156 - 4UG/ML

FDA 510(k)

FDA Class 2 ·Microbiology