10,000 results · 51ms · Sources: EU EUDAMED, US FDA

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

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

Susceptibility Test Cards, Antimicrobial

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

Somatic Gene Mutation Detection System

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

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·THXID BRAF KIT

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·THXID™-BRAF

Susceptibility Test Cards, Antimicrobial

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

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval
FDA Class 3 ·VIDAS FREE PSA RT ASSAY

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

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

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval
FDA Class 2 ·VITEK 2 SYSTEM, MODELS VITEK 2 AND VITEK 2 XL

Susceptibility Test Cards, Antimicrobial

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

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 HIGH-LEVEL STREPTOMYCIN

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 SYSTEMS GENERAL SUSCEPTIBILITY CARD

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval
FDA Class 2 ·VITEK(R) AMPICILLIN/SULBACTAM

Accessories, Soft Lens Products

FDA Pre-Market Approval
FDA Class 2 ·NOR-SA-TAB

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 ERYTHROMYCIN

Susceptibility Test Cards, Antimicrobial

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

Susceptibility Test Cards, Antimicrobial

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