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Results for “Anti-Cyclic Citrullinated Peptide Antibody Assay Kit (Fluorescence Immunochromatographic Assay)”

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Registry EUDAMED 13 FDA 510(k) incl. De Novo FDA PMA GUDID

Country / market European Union (all) 13

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Spain 8 Austria 4 Italy 1

Risk class Class I Class IIa Class IIb Class III Class II (US)

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Class A Class B 1 Class C Class D IVD General 12 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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13 devices foundsorted by relevance

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Anti-Cyclic Citrullinated Peptide Antibody Determination Kit (Fluorescence Immunochromatographic Assay)

Beijing Diagreat Biotechnologies Co., Ltd.,China

Active Regimes: CE IVDR Registry: EUDAMED Class:B
Anti-Cyclic Citrullinated Peptide Antibody Assay Kit (Fluorescence Immunochromatographic Assay)

Wuhan Life Origin Biotech Joint Stock Co., Ltd.,China Group of variants

Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General
Anti-Cyclic Citrullinated Peptide IgG antibody (Anti-CCP-IgG) Quantitative Test Kit(Dry Fluorescence Immunochromatographic Assay, FIA)

Jiangsu Confidence Medical Technology Co., Ltd,China Group of variants

Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General
Anti-cyclic Citrullinated Peptide Antibody Rapid Test Kit (Fluorescence Immunochromatographic Assay)

Hoyotek Biomedical Co., Ltd.,China Group of variants

Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

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