IMAGEN INFLUENZA VIRUS A AND B TESTMI

FDA 510(k)

FDA Class 1 ·Microbiology

QUICK VUE INFLUENZA

FDA 510(k)

FDA Class 1 ·Microbiology

DIRECTIGEN FLU A

FDA 510(k)

FDA Class 1 ·Microbiology

INFLUENZA HA ANTIGEN

FDA 510(k)

FDA Class 1 ·Microbiology

INFLUENZA A2 VIRUS

FDA 510(k)

FDA Class 1 ·Microbiology

BARTEL PRIMA SYSTEM INFLUENZA A ENZYME IMMUNOASSAY

FDA 510(k)

FDA Class 1 ·Microbiology

IN FLUENZA B VIRUS

FDA 510(k)

FDA Class 1 ·Microbiology

ANTIBODY ASSAY FOR DETECTION OF INFLUENZA B

FDA 510(k)

FDA Class 1 ·Microbiology

OSOM INFLUENZA A&B TEST MODEL 190

FDA 510(k)

FDA Class 1 ·Microbiology

INFLUENZA A & B S-ANTIGEN & CONTROLS

FDA 510(k)

FDA Class 1 ·Microbiology

FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE A

FDA 510(k)

FDA Class 1 ·Microbiology

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS ANTI-HBC IMMUNOASSAY ON THE MODULAR ANALYSTICS E170 IMMUNOASSAY ANALYZER

D3 Ultra Duet DFA Respiratory Virus

FDA registration

Ortho-Clinical Diagnostics, Inc.·5 products·🇺🇸 United States

EBC EUROPE

Importer

🇫🇷 France·8 Manufacturers

Morgan™ HLA SSP ABC Typing Kit, 1 tests/tray

Basic UDI-DI

EU IVDD · Eu Ivd Annex 2 List B ·TBG Biotechnology Corp.·1 device

O3 Optika Kft.

Importer

🇭🇺 Hungary

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT CORE-M Reagent Kit, Alinity i Anti-HBc IgM Reagent Kit

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT CORE-M Reagent Kit, Alinity i Anti-HBc IgM Reagent Kit

Probe Covers (YF-001, YF-002)

FDA 510(k)

FDA Class 2 ·General Hospital

DIGITEK TITANIUM ABUTMENT

FDA 510(k)

FDA Class 2 ·Dental