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Results for “cTnI Immunofluorescence Assay”

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Registry EUDAMED 20 FDA 510(k) FDA PMA GUDID

Country / market European Union (all) 19

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Romania 18 Spain 1 Türkiye 1

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Class A Class B Class C 1 Class D IVD General 19 IVD Annex II List A IVD Annex II List B IVD for self-testing Active implantable (AIMDD) Unclassified (FDA) Not classified (FDA)

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20 devices foundsorted by relevance

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cTnI Immunofluorescence Assay UDI-DI 06975599466961

Guangzhou KOFA Biotechnology Co., Ltd.,China IVD General

Active CE IVDD EUDAMED IVD General
6 variants
- cTnI Immunofluorescence Assay GP-CT05-B
- cTnI Immunofluorescence Assay GP-CT05-C
- cTnI Immunofluorescence Assay GP-CT05-D
- cTnI Immunofluorescence Assay GQ-CT05-B
- cTnI Immunofluorescence Assay GQ-CT05-C
cTnI/NT-proBNP/D-Dimer Immunofluorescence Assay UDI-DI 06975599465865

Guangzhou KOFA Biotechnology Co., Ltd.,China IVD General

Active CE IVDD EUDAMED IVD General
6 variants
- cTnI/NT-proBNP/D-Dimer Immunofluorescence Assay GP-CND19-B
- cTnI/NT-proBNP/D-Dimer Immunofluorescence Assay GP-CND19-C
- cTnI/NT-proBNP/D-Dimer Immunofluorescence Assay GP-CND19-D
- cTnI/NT-proBNP/D-Dimer Immunofluorescence Assay GQ-CND19-C
- cTnI/NT-proBNP/D-Dimer Immunofluorescence Assay GQ-CND19-E
cTnI/MYO/CK-MB Immunofluorescence Assay UDI-DI 06975599466763

Guangzhou KOFA Biotechnology Co., Ltd.,China IVD General

Active CE IVDD EUDAMED IVD General
6 variants
- cTnI/MYO/CK-MB Immunofluorescence Assay GP-CMC08-C
- cTnI/MYO/CK-MB Immunofluorescence Assay GP-CMC08-D
- cTnI/MYO/CK-MB Immunofluorescence Assay GQ-CMC08-B
- cTnI/MYO/CK-MB Immunofluorescence Assay GQ-CMC08-C
- cTnI/MYO/CK-MB Immunofluorescence Assay GQ-CMC08-E
hs-cTnI Fast Test Kit (Immunofluorescence Assay)

Getein Biotech, Inc,China Class C

Active CE IVDR EUDAMED C
hs-cTnI Fast Test Kit (Immunofluorescence Assay)

Getein Biotech, Inc,China IVD General

Active CE IVDD EUDAMED IVD General

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