225 results · 8ms · Sources: EU EUDAMED, US FDA

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HBV / HCV / HIV COMBINATION - MULTIPLEX NA REAGENTS

Device
EU IVDD · Eu Ivd Annex 2 List A ·Sanway Gene Tech. Inc.·On the market·3 countries

Sansure Biotech Inc.

Manufacturer
🇨🇳 China·1252 Basic UDI-DIs·1376 Devices·4 Importers·TÜV SÜD Product Service GmbH, CeCert Sp. z o.o., CeCert Sp. z o.o., CeCert Sp. z o.o., CeCert Sp. z o.o., CeCert Sp. z o.o., CeCert Sp. z o.o., and POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

Changsha Sinocare Inc.

Manufacturer
🇨🇳 China·67 Basic UDI-DIs·68 Devices·1 Importer·TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH

Apex Biotechnology Corp.

Manufacturer
🇹🇼 Taiwan·40 Basic UDI-DIs·40 Devices·2 Importers·TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, and TÜV Rheinland LGA Products GmbH

Sanway Gene Tech. Inc.

Manufacturer
🇨🇳 China·1 Basic UDI-DI·1 Device·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. and POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

GC MEDIS Corp.

Manufacturer
🇰🇷 South Korea·31 Basic UDI-DIs·31 Devices·TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH

GB Lifecare Co., Ltd.

Manufacturer
🇰🇷 South Korea·2 Basic UDI-DIs·2 Devices·TÜV Rheinland LGA Products GmbH

SHANGHAI ZJ BIO-TECH CO., LTD

Manufacturer
🇨🇳 China·297 Basic UDI-DIs·326 Devices·2 Importers·TÜV Rheinland LGA Products GmbH

Hepatitis B Virus DNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

Device
EU IVDD · Eu Ivd Annex 2 List A ·Sansure Biotech Inc.·On the market

Hepatitis C Virus RNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

Device
EU IVDD · Eu Ivd Annex 2 List A ·Sansure Biotech Inc.·On the market·3 countries

Human Immunodeficiency Virus Type 1 RNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

Device
EU IVDD · Eu Ivd Annex 2 List A ·Sansure Biotech Inc.·On the market

KET-1

Device
EU IVDD · Eu Ivd Self Testing ·Apex Biotechnology Corp.·No longer on the market

Contrex Plus III

Device
EU IVDD · Eu Ivd Annex 2 List B ·Apex Biotechnology Corp.·On the market

GlucoSure Autocode

Device
EU IVDD · Eu Ivd Annex 2 List B ·Apex Biotechnology Corp.·On the market

UASure II

Device
EU IVDD · Eu Ivd Self Testing ·Apex Biotechnology Corp.·On the market·4 countries

HemoSmart GOLD

Device
EU IVDD · Eu Ivd Self Testing ·Apex Biotechnology Corp.·On the market·3 countries

HemoSmart GOLD

Device
EU IVDD · Eu Ivd Self Testing ·Apex Biotechnology Corp.·On the market·3 countries

THE EDGE

Device
EU IVDD · Eu Ivd Self Testing ·Apex Biotechnology Corp.·On the market·6 countries

THE EDGE

Device
EU IVDD · Eu Ivd Self Testing ·Apex Biotechnology Corp.·On the market·6 countries

GLUCOSE TEST STRIPS

Device
EU IVDD · Eu Ivd Self Testing ·Changsha Sinocare Inc.·On the market