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

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

Nitta M&T Safety Box

FDA 510(k)

FDA Class 2 ·General Hospital

SurgiCube

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 GRAM NEGATIVE AST FOR AMIKACIN

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 2 SYSTEM, MODELS VITEK 2 AND VITEK 2 XL