19 results · 41ms · Sources: EU EUDAMED, US FDA

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

FDA classification
FDA Class 3 ·Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

Brush, Biopsy, Bronchoscope (Non-Rigid)

FDA classification
FDA Class 2 ·Brush, Biopsy, Bronchoscope (Non-Rigid)

Magnet, Test, Pacemaker

FDA classification
FDA Class 1 ·Magnet, Test, Pacemaker

Assisted Reproduction Laminar Flow Workstation

FDA classification
FDA Class 2 ·Assisted Reproduction Laminar Flow Workstation

Accessory, Assisted Reproduction, Exempt

FDA classification
FDA Class 2 ·Accessory, Assisted Reproduction, Exempt

Dna And Rna Oncology Controls

FDA classification
FDA Class 2 ·Dna And Rna Oncology Controls

Hematopoietic Cell Enrichment Kit

FDA classification
FDA Class 2 ·Hematopoietic Cell Enrichment Kit

Fluorescence In Situ Hybridization, Platelet-Derived Growth Factor Receptor, Beta Polypeptide (Pdgfrb), Rearrangement

FDA classification
FDA Class 3 ·Fluorescence In Situ Hybridization, Platelet-Derived Growth Factor Receptor, Beta Polypeptide (Pdgfrb), Rearrangement

Kappa And Lambda Immunoglobulin Light Chain In Situ Hybridization Mrna Probe Detection Kit

FDA classification
FDA Class 2 ·Kappa And Lambda Immunoglobulin Light Chain In Situ Hybridization Mrna Probe Detection Kit

Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)

FDA classification
FDA Class 3 ·Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)

Spinal Muscular Atrophy Newborn Screening Test System

FDA classification
FDA Class 2 ·Spinal Muscular Atrophy Newborn Screening Test System

Quality Control Material, Genetics, Rna

FDA classification
FDA Class 2 ·Quality Control Material, Genetics, Rna

Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies

FDA classification
FDA Class 2 ·Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies

Cancer Predisposition Risk Assessment System

FDA classification
FDA Class 2 ·Cancer Predisposition Risk Assessment System

Whole Exome Sequencing Constituent Device

FDA classification
FDA Class 2 ·Whole Exome Sequencing Constituent Device

Hiv-1 Genotyping Assay Using Ngs Technology

FDA classification
FDA Class 2 ·Hiv-1 Genotyping Assay Using Ngs Technology

Direct-To-Consumer Access Pharmacogenetic Assessment System

FDA classification
FDA Class 2 ·Direct-To-Consumer Access Pharmacogenetic Assessment System

Bcr/Abl1 Monitoring Test

FDA classification
FDA Class 2 ·Bcr/Abl1 Monitoring Test

Jak2 Gene Mutation Detection Test

FDA classification
FDA Class 2 ·Jak2 Gene Mutation Detection Test