Optilite FreeLite Kappa Free Kit, Optilite Freelite Lambda Free Kit

FDA 510(k)

FDA Class 2 ·Immunology

Human Microalbumin kit for use on SPAPLUS

FDA 510(k)

FDA Class 2 ·Immunology

Hevylite Human IgA Kappa Kit for use on SPAPLUS, Hevylite Human IgA Lambda Kit for use on SPAPLUS

FDA 510(k)

FDA Class 2 ·Immunology

C-Reactive Protein Kit for use on SPAPLUS

FDA 510(k)

FDA Class 2 ·Immunology

HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KIT

FDA 510(k)

FDA Class 2 ·Immunology

REPOSITIONABLE BITEWING X-RAY FILM HOLDER KIT

FDA 510(k)

FDA Class 1 ·Dental

Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 Calibrator

FDA 510(k)

FDA Class 2 ·Immunology

HEVYLITE HUMAN IGM KAPPA AND HEVYLITE IGM LAMBDA KIT

FDA 510(k)

FDA Class 2 ·Immunology

HUMAN BETA-2 MICROGLOBULIN URINE KIT FOR USE ON THE SPAPLUS

FDA 510(k)

FDA Class 2 ·Immunology

Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit

FDA 510(k)

FDA Class 2 ·Immunology

Optilite IgA Kit

FDA 510(k)

FDA Class 2 ·Immunology

Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls

FDA 510(k)

FDA Class 2 ·Immunology

Optilite Rheumatoid Factor Kit

FDA 510(k)

FDA Class 2 ·Immunology

Optilite IgM CSF Kit

FDA 510(k)

FDA Class 2 ·Immunology

Optilite IgM Kit

FDA 510(k)

FDA Class 2 ·Immunology

Human IgM Kit for use on SPAPlus

FDA 510(k)

FDA Class 2 ·Immunology

YouSeq SARS-CoV-2 Multiplex qRT-PCR kit

Basic UDI-DI

EU IVDD · Eu Ivd General ·YouSeq Ltd·1 device

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA Pre-Market Approval

FDA Class 3 ·QuantiFERON®-TB Gold, QuantiFERON®-TB Gold Plus

SARS-CoV-2 Nucleic Acid Detection Kit（qRT-PCR）

Basic UDI-DI

EU IVDD · Eu Ivd General ·Geneseeq Medical Device and Diagnostic Inc.·1 device

QT ECG Recorder

Basic UDI-DI

EU MDD · Eu Md Class 2a ·QT Medical, Inc.·1 device