17 results
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17ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Finland
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Facit hCG
Device
EU IVDD
·
Eu Ivd General
·Aidian Oy·On the market
DELFIA hCG
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·Wallac Oy·On the market·32 countries
AutoDELFIA hCG
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·Wallac Oy·On the market·32 countries
DELFIA Xpress hCG kit
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·Wallac Oy·On the market·32 countries
DELFIA Xpress hCG kit
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·Wallac Oy·On the market·32 countries
AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-112 - Product Usage: Quantitative determination of human gonadotrophin (hCG).
FDA Enforcement
Class II
·Ongoing·PerkinElmer Life and Analytical Sciences, Wallac, OY·May 8, 2019
AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-101 - Product Usage: Quantitative determination of human gonadotrophin (hCG).
FDA Enforcement
Class II
·Ongoing·PerkinElmer Life and Analytical Sciences, Wallac, OY·May 8, 2019
DELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: A007-101 - Product Usage: Quantitative determination of human gonadotrophin (hCG) in serum.
FDA Enforcement
Class II
·Ongoing·PerkinElmer Life and Analytical Sciences, Wallac, OY·May 8, 2019
Facit hCG
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Aidian Oy·1 device
AutoDELFIA hCG
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List B
·Wallac Oy·1 device
DELFIA hCG
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List B
·Wallac Oy·1 device
DELFIA Xpress hCG kit
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List B
·Wallac Oy·1 device
DELFIA Xpress hCG kit
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List B
·Wallac Oy·1 device
Albumin (BCG)
Device
EU IVDR
·
Eu Ivd Class B
·Thermo Fisher Scientific Oy·On the market·28 countries
CARDIOCAP II CG-2GS, 2G, 1GS, 1G, 2CG, CS MONITOR
FDA 510(k)
FDA Class 1
·Cardiovascular
Albumin (BCG)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Thermo Fisher Scientific Oy·1 device
Albumin (BCG)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Thermo Fisher Scientific Oy·1 device