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

NxTAG® Respiratory Pathogen Panel

FDA 510(k)

FDA Class 2 ·Microbiology

EFILM WORKSTATION

FDA 510(k)

FDA Class 2 ·Radiology

TAG RESPIRATORY VIRAL PANEL TAG DATA ANALYSIS SOFTWARE (TDAS RVP-I)

FDA 510(k)

FDA Class 2 ·Microbiology

LUMINEX LX 100/200 INSTRUMENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VIEWING CLIENT MOBILE

FDA 510(k)

FDA Class 2 ·Radiology

xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)

FDA 510(k)

FDA Class 2 ·Microbiology

BrightMatter Guide with BrightMatter Pointer

FDA 510(k)

FDA Class 2 ·Neurology

XTAG RESPIRATORY VIRAL PANEL FAST, XTAG DATA ANALYSIS SOFTWARE FOR RVP FAST

FDA 510(k)

FDA Class 2 ·Microbiology

xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)

FDA 510(k)

FDA Class 2 ·Microbiology

XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS)

FDA 510(k)

FDA Class 2 ·Microbiology