10,000 results · 44ms · Sources: EU EUDAMED, US FDA

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval
FDA Class 2 ·VITEK(R) 2 GRAM POSITIVE AST FOR MINOCYCLINE

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·THxID BRAF assay kit

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 ·AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval
FDA Class 2 ·VITEK GRAM NEGATIVE SUSCEPTIBILITY CARD-CEFTRIAXONE

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval
FDA Class 2 ·VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval
FDA Class 2 ·VITEK 2 GRAM POSITIVE AST FOR CEFTRIAXONE

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval
FDA Class 3 ·VIDAS TOTAL PSA

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 2 GRAM POSITIVE AST FOR CHLORAMPHENICOL

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 2 GRAM NEGATIVE AST FOR CEFOXITIN

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval
FDA Class 3 ·VIDAS TPSA ASSAY

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval
FDA Class 2 ·VITEK(R) GRAM POSITIVE AST FOR NITROFURANTOIN

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval
FDA Class 2 ·VITEK 2 GRAM NEGATIVE AST FOR TOBRAMYCIN

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval
FDA Class 2 ·AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval
FDA Class 2 ·VITEK 2 GRAM POSITIVE AST FOR GENTAMICIN

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 SYSTEMS GENERAL SUSCEPTIBILITY CARD

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval
FDA Class 2 ·VITEK 2 SYSTEM