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

Exercise Equipment, Powered, Emg-Triggered

FDA classification

FDA Class 2 ·Exercise Equipment, Powered, Emg-Triggered

Uterine Electromyographic Monitor

FDA classification

FDA Class 2 ·Uterine Electromyographic Monitor

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

Stimulator, Intramuscular, Automatic

FDA classification

FDA Class 2 ·Stimulator, Intramuscular, Automatic

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

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

Spinal Muscular Atrophy Newborn Screening Test System

FDA classification

FDA Class 2 ·Spinal Muscular Atrophy Newborn Screening Test System