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

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

AmplideX Fragile X Dx & Carrier Screen Kit

FDA 510(k)

FDA Class 2 ·Immunology

Invitae Common Hereditary Cancers Panel

FDA 510(k)

FDA Class 2 ·Pathology

Adaptive Biotechnologies clonoSEQ Assay

FDA 510(k)

FDA Class 2 ·Pathology

VENTANA CD30 (Ber-H2) RxDx Assay

FDA 510(k)

FDA Class 2 ·Immunology

xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR

FDA 510(k)

FDA Class 2 ·Immunology

Parsortix PC1 Device

FDA 510(k)

FDA Class 2 ·Immunology

GenetiSure Dx Postnatal Assay

FDA 510(k)

FDA Class 2 ·Immunology

xTAG Cystic Fibrosis 39 Kit v2

FDA 510(k)

FDA Class 2 ·Immunology

Plexus

FDA 510(k)

FDA Class 2 ·Cardiovascular

extriCARE 1000 Negative Pressure Wound Therapy System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Injector, Jet, Gas-Powered

FDA classification

FDA Class 2 ·Injector, Jet, Gas-Powered

Assisted Reproduction Laminar Flow Workstation

FDA classification

FDA Class 2 ·Assisted Reproduction Laminar Flow Workstation

Analyzer, Nitrogen Dioxide, Exempt

FDA classification

FDA Class 2 ·Analyzer, Nitrogen Dioxide, Exempt

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