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

IFA SENSIBAC VANCOMYCIN

FDA 510(k)

FDA Class 2 ·Microbiology

IFA SENSIBAC TOBRAMYCIN

FDA 510(k)

FDA Class 2 ·Microbiology

THROMBOSTIN IFA*

FDA 510(k)

FDA Class 2 ·Hematology

PACS CORE/ENCORE

FDA 510(k)

FDA Class 2 ·Radiology

IFA SENSIBAC GENTAMYCIN

FDA 510(k)

FDA Class 2 ·Microbiology

BRUCELLA IFA*

FDA 510(k)

FDA Class 2 ·Microbiology

NIKKICART

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VEN-O-VAC BLOOD COLLECTION VACUUM TUBES

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

IFA SENSIBAC NITROFURANTOIN

FDA 510(k)

FDA Class 2 ·Microbiology