10,000 results · 46ms · 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