940 results · 21ms · Sources: EU EUDAMED, US FDA

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval
FDA Class 2 ·ST AIA-PACK PA

CANDIDA IMMUNODIFFUSION KIT #CA1001

FDA 510(k)
FDA Class 2 ·Microbiology

FUNGAL IMMUNODIFFUSION SYSTEM

FDA 510(k)
FDA Class 2 ·Microbiology

CANDIDA IMMUNODIFFUSION KIT

FDA 510(k)
FDA Class 2 ·Microbiology

CANDIDA ALBICANS, ANTIGEN

FDA 510(k)
FDA Class 2 ·Microbiology

OLYMPUS PK-TP SYSTEM REACTIVE CONTROL

FDA 510(k)
FDA Class 2 ·Microbiology

COCCIDIOIDES IMMUNODIFFUSION SYSTEM

FDA 510(k)
FDA Class 2 ·Microbiology

COCCIDIOIDES IMMITIS, ANTIGEN

FDA 510(k)
FDA Class 2 ·Microbiology

IMMUNODIFFUSION REAGENTS/SEROLOGICAL

FDA 510(k)
FDA Class 2 ·Microbiology

COCCIDIOIDES ANTIGEN #CF10023X

FDA 510(k)
FDA Class 2 ·Microbiology

CANDIDA ALBICANS, ANTISERUM

FDA 510(k)
FDA Class 2 ·Microbiology

COCCIDIOIDES IMMITIS, ANTIGEN

FDA 510(k)
FDA Class 2 ·Microbiology

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT AXSYM HAVAB 2.0

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·VERSANT HCV GENOTYPE 2.0 ASSAY (LiPA)

Susceptibility Test Cards, Antimicrobial

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

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·LIAISON XL MUREX HCV Ab; LIAISON XL MUREX Control HCV Ab

Hearing Aid, Master

FDA classification
FDA Class 2 ·Hearing Aid, Master

Aid, Cardiopulmonary Resuscitation

FDA classification
FDA Class 2 ·Aid, Cardiopulmonary Resuscitation

DermaSensor

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

AMEBIASIS BIO-ENZABEAD SCREEN KIT

FDA 510(k)
FDA Class 2 ·Microbiology