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

D3 Ultra Duet DFA Respiratory Virus

FDA registration

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

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC MODEL 7221 B/C/CX/D/E MICRO JEWEL W/MODEL 5434 ACTIVE CAN EMULATOR AND MODEL 9894

Nebulizer

Basic UDI-DI

EU MDR · Eu Md Class 2a ·BMC Medical Co., Ltd.·2 devices

Heated Humidifier

Basic UDI-DI

EU MDR · Eu Md Class 2a ·BMC Medical Co., Ltd.·1 device

Respiration Data Management Software

Basic UDI-DI

EU MDR · Eu Md Class 2a ·BMC Medical Co., Ltd.·3 devices

Oxygen Concentrator

Basic UDI-DI

EU MDR · Eu Md Class 2b ·BMC Medical Co., Ltd.·2 devices

Water Chamber

Basic UDI-DI

EU MDR · Eu Md Class 2a ·BMC Medical Co., Ltd.·1 device

Sleep Apnea Diagnosis Device

Basic UDI-DI

EU MDR · Eu Md Class 2a ·BMC Medical Co., Ltd.·6 devices

Mask

Basic UDI-DI

EU MDR · Eu Md Class 2a ·BMC Medical Co., Ltd.·110 devices

Tube

Basic UDI-DI

EU MDR · Eu Md Class 2a ·BMC Medical Co., Ltd.·5 devices

Nasal Cannula

Basic UDI-DI

EU MDR · Eu Md Class 2a ·BMC Medical Co., Ltd.·6 devices

Respiratory High-Flow Therapy Device

Basic UDI-DI

EU MDR · Eu Md Class 2a ·BMC Medical Co., Ltd.·8 devices