10,000 results
·
43ms
·
Sources: EU EUDAMED, US FDA
Susceptibility Test Cards, Antimicrobial
FDA Pre-Market Approval
FDA Class 2
·VITEK(R) 2 GRAM POSITIVE AST FOR TRIMETHOPRIM/SULFAMETHOXAZOLE
Susceptibility Test Cards, Antimicrobial
FDA Pre-Market Approval
FDA Class 2
·AMMENDMENT TO E. COLI ASC
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·VIDAS TOTAL PSA
System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection
FDA Pre-Market Approval
FDA Class 3
·ColoSense
Susceptibility Test Cards, Antimicrobial
FDA Pre-Market Approval
FDA Class 2
·VITEK 2 GRAM NEGATIVE AST FOR GENTAMICIN
Susceptibility Test Cards, Antimicrobial
FDA Pre-Market Approval
FDA Class 2
·VITEK 2 GRAM POSITIVE AST FOR SPARFLOXACIN
Excimer Laser System
FDA Pre-Market Approval
FDA Class 3
·LASERVISION/VISX EXCIMER LASER FOR PRK AND PTK (MOBILEXCIMER)
Susceptibility Test Cards, Antimicrobial
FDA Pre-Market Approval
FDA Class 2
·AMMENDMENT TO E. COLI ASC
Susceptibility Test Cards, Antimicrobial
FDA Pre-Market Approval
FDA Class 2
·VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR QUINUPRISTIN/DALFOPRISTIN
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·THxID-BRAF assay kit
Susceptibility Test Cards, Antimicrobial
FDA Pre-Market Approval
FDA Class 2
·AMS CEFOTETAN CARD
Susceptibility Test Cards, Antimicrobial
FDA Pre-Market Approval
FDA Class 2
·VITEK 2 GRAM NEGATIVE AST FOR AMPICILLIN
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·VIDAS TOTAL PSA (TPSA)
System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection
FDA Pre-Market Approval
FDA Class 3
·ColoSense®
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·THxID-BRAF kit
Susceptibility Test Cards, Antimicrobial
FDA Pre-Market Approval
FDA Class 2
·VITEK(R) 2 GRAM POSITIVE AST FOR CEFAZOLIN
Susceptibility Test Cards, Antimicrobial
FDA Pre-Market Approval
FDA Class 2
·AMMENDMENT TO E. COLI ASC
Susceptibility Test Cards, Antimicrobial
FDA Pre-Market Approval
FDA Class 2
·VITEK(R) 2 GRAM NEGATIVE AST FOR IMIPENEM
Susceptibility Test Cards, Antimicrobial
FDA Pre-Market Approval
FDA Class 2
·VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR GATIFLOXACIN
Susceptibility Test Cards, Antimicrobial
FDA Pre-Market Approval
FDA Class 2
·VITEK 2 GRAM POSITIVE AST FOR CEFOTAXIME