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