322 results
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9ms
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Sources: EU EUDAMED, US FDA
HIV AG/AB COMBI - RT & POC
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·Abbott Diagnostics Medical Co., Ltd.·On the market·15 countries
OnSite HIV 1/2 Ab Plus Combo Rapid Test
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·CTK Biotech Inc.·On the market·1 country
Daan Gene Co., Ltd.
Manufacturer
🇨🇳 China·127 Basic UDI-DIs·194 Devices·CeCert Sp. z o.o., CeCert Sp. z o.o., CeCert Sp. z o.o., CeCert Sp. z o.o., and CeCert Sp. z o.o.
Abbott Diagnostics Medical Co., Ltd.
Manufacturer
🇯🇵 Japan·4 Basic UDI-DIs·4 Devices·1 Importer·TÜV SÜD Product Service GmbH and TÜV SÜD Product Service GmbH
iXensor Co., Ltd.
Manufacturer
🇹🇼 Taiwan·8 Basic UDI-DIs·8 Devices·BSI Group The Netherlands B.V. and BSI Group The Netherlands B.V.
Tyson Bioresearch, Inc.
Manufacturer
🇹🇼 Taiwan·24 Basic UDI-DIs·24 Devices·1 Importer·Eurofins Electric & Electronics Finland Oy and Eurofins Electric & Electronics Finland Oy
General Life Biotechnology Co., Ltd.
Manufacturer
🇹🇼 Taiwan·72 Basic UDI-DIs·72 Devices·TÜV Rheinland LGA Products GmbH and TÜV Rheinland LGA Products GmbH
CTK Biotech Inc.
Manufacturer
🇺🇸 United States·1 Basic UDI-DI·1 Device·3EC International a.s.
Biomerica, Inc.
Manufacturer
🇺🇸 United States·28 Basic UDI-DIs·28 Devices·1 Importer·GMED SAS
W.H.P.M. Bioresearch & Technology Co., Ltd.
Manufacturer
🇨🇳 China·27 Basic UDI-DIs·27 Devices·7 Importers·TÜV Rheinland LGA Products GmbH
OK biotech co., Ltd
Manufacturer
🇹🇼 Taiwan·1 Basic UDI-DI·1 Device·1 Importer·TÜV SÜD Product Service GmbH
AccuBioTech Co., Ltd.
Manufacturer
🇨🇳 China·6 Basic UDI-DIs·6 Devices·TÜV Rheinland LGA Products GmbH
HEPATITIS C VIRUS - NA REAGENTS
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·Daan Gene Co., Ltd.·On the market
HEPATITIS B VIRUS - NA REAGENTS
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·Daan Gene Co., Ltd.·On the market
Determine
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·Abbott Diagnostics Medical Co., Ltd.·On the market
One-Step Drug of Abuse Test Tricyclic Antidepressants (TCA)
Device
EU IVDD
·
Eu Ivd Self Testing
·W.H.P.M. Bioresearch & Technology Co., Ltd.·On the market
One-Step Drug of Abuse Test -Methylenedioxymethamphetamine (MDMA)
Device
EU IVDD
·
Eu Ivd Self Testing
·W.H.P.M. Bioresearch & Technology Co., Ltd.·On the market
One-Step Drug Of Abuse Test 2-Ethylidene-1,5-dimethyl-3,3-dipheylpyrrolidine (EDDP)
Device
EU IVDD
·
Eu Ivd Self Testing
·W.H.P.M. Bioresearch & Technology Co., Ltd.·On the market
One-Step Drug Of Abuse Test -Morphine (MOR)
Device
EU IVDD
·
Eu Ivd Self Testing
·W.H.P.M. Bioresearch & Technology Co., Ltd.·On the market
One-Step Drug Of Abuse Test -Buprenorphine (BUP)
Device
EU IVDD
·
Eu Ivd Self Testing
·W.H.P.M. Bioresearch & Technology Co., Ltd.·On the market