105 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN-TAZOBACTAM (GP) 1/4-128/4 UG/ML
FDA 510(k)
FDA Class 2
·Microbiology
BD Phoenix Automated Microbiology System - GN Ceftolozane/tazobactam (0.25/4-32/4 ug/mL)
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
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN-0.125-8 AND CIPROFLOXACIN-0.25 - 4 UG/ML
FDA 510(k)
FDA Class 2
·Microbiology
Susceptibility Test Cards, Antimicrobial
FDA Pre-Market Approval
FDA Class 2
·VITEK(R) 2 GRAM POSITIVE AST FOR MINOCYCLINE
Susceptibility Test Cards, Antimicrobial
FDA Pre-Market Approval
FDA Class 2
·VITEK 2 GRAM POSITIVE AST FOR VANCOMYCIN
DD Bio Z, DD Bio ZX(square), DD BioZX(square) color
FDA 510(k)
FDA Class 2
·Dental
DD BIO Z AND DD BIO Z - TRANSPA
FDA 510(k)
FDA Class 2
·Dental
MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 - 16/4 ug/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
MicroScan Dried Gram Negative MIC/Combo Panels with Ceftazidime/Avibactam (0.25/4 - 64/4 ug/mL)
FDA 510(k)
FDA Class 2
·Microbiology
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERYTHROMYCIN-0.0625-8 UG/ML, AND QUINUPRISTIN/DALFOPRISTIN-0.25-4 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
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Imipenem-Relebactam in the dilution range of 0.03/4-256/4 ug/mL
FDA 510(k)
FDA Class 2
·Microbiology
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Sulbactam-durlobactam in the dilution range of 0.015/4-32/4 ug/mL
FDA 510(k)
FDA Class 2
·Microbiology
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftazidime/Avibactam in the dilutions range of 0.015/4 - 32/4 ug/mL
FDA 510(k)
FDA Class 2
·Microbiology
IAFP MUELLER HINTON AGAR
FDA 510(k)
FDA Class 2
·Microbiology
IAFP MUELLER HINTON AGAR W/HEMO. W/CVA ENRICHMENT
FDA 510(k)
FDA Class 2
·Microbiology
IAFP MUELLER HINTON AGAR W/5% SHEEP BLOOD
FDA 510(k)
FDA Class 2
·Microbiology
Sensititre 20-24 hour Haemophilus influenzaelStreptococcus pneumoniae MIC or Breakpoint Susceptibility System with Ceftolozane-tazobactam in the dilution range of 0.03/4-64/4ug/ml
FDA 510(k)
FDA Class 2
·Microbiology