8 results
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8ms
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Sources: EU EUDAMED, US FDA
VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE
Device
EU IVDD
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Eu Ivd General
·Sansure Biotech Inc.·On the market
VIROLOGY - NA REAGENTS - OTHER
Device
EU IVDD
·
Eu Ivd General
·Daan Gene Co., Ltd.·On the market
Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold)
Device
EU IVDD
·
Eu Ivd General
·BioDetect(Xiamen)Biotechnology Co., Ltd.·On the market
DP360 Slide Stainer
Device
EU IVDR
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Eu Ivd Class A
·Dakewe (Shenzhen) Medical Equipment Co., Ltd.·On the market·32 countries
SARS-CoV-2 BA.1/BA.2 Mutation Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Sansure Biotech Inc.·1 device
SARS-CoV-2 BA.1/BA.2 Mutation Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Sansure Biotech Inc.·1 device
Analysis Software for PCR-Fluorescence Detection Data
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Sansure Biotech Inc.·1 device
Detection Kit for 2019-nCoV (PCR-Fluorescence)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Daan Gene Co., Ltd.·1 device