10,000 results · 48ms · Sources: EU EUDAMED, US FDA

ipsogen JAK2 RGQ PCR Kit

FDA 510(k)
FDA Class 2 ·Medical Genetics

23andMe Personal Genome Service (PGS) Pharmacogenetic Reports

FDA 510(k)
FDA Class 2 ·Medical Genetics

QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System

FDA 510(k)
FDA Class 2 ·Medical Genetics

ipsogen JAK2 RGQ PCR Kit

FDA 510(k)
FDA Class 2 ·Medical Genetics

MUTYH-Associated Polyposis (MAP)

FDA 510(k)
FDA Class 2 ·Medical Genetics

23andMe Personal Genome Service (PGS) Pharmacogenetic Reports

FDA 510(k)
FDA Class 2 ·Medical Genetics

Helix Laboratory Platform

FDA 510(k)
FDA Class 2 ·Medical Genetics

BCR-ABL1 (p210) % IS Kit (Digital PCR Method)

FDA 510(k)
FDA Class 2 ·Medical Genetics

MLL (KMT2A) Breakapart FISH Probe Kit; AML1 (RUNX1) Breakapart FISH Probe Kit, P53 (TP53) Deletion FISH Probe Kit; EVI1 (MECOM) Breakapart FISH Probe Kit, Del(20q) Deletion FISH Probe Kit; AML1/ETO (RUNX1/RUNXIT1)) Translocation, Dual Fusi, CBFB (CBFB) /MYH11 Translocation, Dual Fusion FISH Probe Kit,Del(5q)Deletion FISH Probe Kit; Del(7q)Deletion FISH Probe Kit

FDA 510(k)
FDA Class 2 ·Medical Genetics

23andMe Personal Genome Service (PGS) Pharmacogenetic Reports

FDA 510(k)
FDA Class 2 ·Medical Genetics

23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)

FDA 510(k)
FDA Class 2 ·Medical Genetics

MRDx BCR-ABL Test, MRDx BCR-ABL Test Software

FDA 510(k)
FDA Class 2 ·Medical Genetics

23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related)

FDA 510(k)
FDA Class 2 ·Medical Genetics

Kazuo Kawasaki

FDA UDI
MASUNAGA OPTICAL MFG.CO.,LTD.·04582644472147·

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·STINGER ABLATION CATHETER; TEMPLINK EXTENSION CABLE

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·LIVEWIRE TC CARDIAC ABLATION SYSTEM

SurgiCube

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

Eonis SCID-SMA kit

FDA 510(k)
FDA Class 2 ·Immunology

Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C

FDA 510(k)
FDA Class 2 ·Immunology

Eonis SCID-SMA Kit

FDA 510(k)
FDA Class 2 ·Immunology