GEM Premier 4000

FDA registration

INSTRUMENTATION LABORATORY CO. - Devens·13 products·🇺🇸 United States

GEM Premier 4000

FDA registration

Instrumentation Laboratory Co.·13 products·🇺🇸 United States

GEM Premier 4000

FDA registration

INSTRUMENTATION LABORATORY CO.·13 products·🇺🇸 United States

GEM Premier 4000

FDA registration

INSTRUMENTATION LABORATORY CO.·13 products·🇺🇸 United States

Infinity Creatinine

FDA registration

Fisher Diagnostics·13 products·🇺🇸 United States

CN23/00006997

Certificate

MDR QA·Shenzhen Zijian Biotechnology Co., Ltd·SGS Belgium NV

CeCert/086/W/E.1

Certificate

IVDD Annex III Section 6·Shenzhen Zijian Biotechnology Co., Ltd·CeCert Sp. z o.o.·2 Basic UDI-DIs

Piccolo Liver Panel Plus

FDA UDI

ABAXIS, INC.·EABA40000031·The Piccolo® Liver Panel Plus, used with the Pi...

Eurolink Europe Compliance Limited

Authorized representative

🇮🇪 Ireland·35 Manufacturers·252 Devices

Etiometry Platform Software

Basic UDI-DI

EU MDR · Eu Md Class 2a ·Etiometry Inc.·1 device

GEM CVP 1 with CO-OX (Orangeburg NY Facility)

FDA registration

INSTRUMENTATION LABORATORY CO.·15 products·🇺🇸 United States

GEM CVP 1 with CO-OX (Orangeburg NY Facility)

FDA registration

INSTRUMENTATION LABORATORY CO.·15 products·🇺🇸 United States

GEM CVP 1 with CO-OX (Orangeburg NY Facility)

FDA registration

Instrumentation Laboratory Co.·15 products·🇺🇸 United States

GEM CVP 1 with CO-OX (Orangeburg NY Facility)

FDA registration

INSTRUMENTATION LABORATORY CO. - Devens·15 products·🇺🇸 United States

Testing pack

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·Shenzhen Zijian Biotechnology Co., Ltd·8 devices

Multifunctional blood analyzer

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·Shenzhen Zijian Biotechnology Co., Ltd·5 devices

SARS-CoV-2(COVID-19)Antigen Rapid Detection Kit(Lateral Flow Method)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Shenzhen Zijian Biotechnology Co., Ltd·1 device

SARS-CoV-2（COVID-19）Antigen Rapid Detection Kit (Lateral Flow Method)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Shenzhen Zijian Biotechnology Co., Ltd·1 device

SARS-CoV-2（COVID-19）Antigen Rapid Detection Kit (Lateral Flow Method)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Shenzhen Zijian Biotechnology Co., Ltd·1 device

Disposable Virus Sampling Tube

Basic UDI-DI

EU IVDD · Eu Ivd General ·Shenzhen Zijian Biotechnology Co., Ltd·1 device