2,731 results · 45ms · Sources: EU EUDAMED, US FDA

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GenomEra® SARS-CoV-2 Assay Kit

Device
EU IVDD · Eu Ivd General ·Abacus Diagnostica Oy·On the market

GenomEra® SARS-CoV-2 Assay Kit

Device
EU IVDD · Eu Ivd General ·Abacus Diagnostica Oy·On the market

SARS-CoV-2 Neutralizing Antibody Test Kit

Device
EU IVDD · Eu Ivd General ·MedicalSystem Biotechnology Co., Ltd.·On the market

IDTM SARS-CoV-2 / VOC Revolution Pentaplex

Device
EU IVDD · Eu Ivd General ·ID SOLUTIONS·On the market

IDTM SARS-CoV-2 / VOC Revolution Pentaplex

Device
EU IVDD · Eu Ivd General ·ID SOLUTIONS·On the market

SARS-CoV-2 Antigen Rapid Test Cassette

Device
EU IVDD · Eu Ivd Self Testing ·Merlin Biomedical (Xiamen) Co., Ltd.·On the market

ACCESS SARS-CoV-2 IgM (reagent pack)

Device
EU IVDD · Eu Ivd General ·Beckman Coulter Inc.·On the market·32 countries

Access SARS-CoV-2 IgG (reagent pack)

Device
EU IVDD · Eu Ivd General ·Beckman Coulter Inc.·On the market·32 countries

Access SARS-CoV-2 IgG II QC

Device
EU IVDD · Eu Ivd General ·Beckman Coulter Inc.·On the market·32 countries

Access SARS-CoV-2 IgG II Calibrators

Device
EU IVDD · Eu Ivd General ·Beckman Coulter Inc.·On the market·32 countries

mariPOC® SARS-CoV-2 test reagent

Device
EU IVDD · Eu Ivd General ·ArcDia International Oy Ltd·On the market

BOVINE PRECISION MULTI SERA - LEVEL 1 (BOV PREC CONTROL 1)

FDA UDI
RANDOX LABORATORIES LIMITED·05055273206258·

ASSAYED BOVINE MULTI SERA - LEVEL 3 (BOV ASY CONTROL 3)

FDA UDI
RANDOX LABORATORIES LIMITED·05055273200119·

BOVINE PRECISION MULTI SERA - LEVEL 2 (BOV PREC CONTROL 2)

FDA UDI
RANDOX LABORATORIES LIMITED·05055273206272·

ASSAYED BOVINE MULTI SERA - LEVEL 2 (BOV ASY CONTROL 2)

FDA UDI
RANDOX LABORATORIES LIMITED·05055273200294·

BOVINE PRECISION MULTI SERA - LEVEL 3 (BOV PREC CONTROL 3)

FDA UDI
RANDOX LABORATORIES LIMITED·05055273206173·

ASSAYED BOVINE MULTI SERA - LEVEL 1 (BOV ASY CONTROL 1)

FDA UDI
RANDOX LABORATORIES LIMITED·05055273200140·

FilmArray Respiratory Panel 2 plus (RP2plus)

FDA 510(k)
FDA Class 2 ·Pathology

ACCURUN Anti-SARS-CoV-2 IgM Controls Kit

Device
EU IVDD · Eu Ivd General ·LGC Clinical Diagnostics, Inc.·On the market

SARS-CoV-2 nucleic acid easyPCR detection kit

Device
EU IVDD · Eu Ivd General ·TargetingOne Technology (Beijing) Corporation·On the market