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Results for “α-fetoprotein (AFP) Diagnostic Kit (Immunochromatographic Assay)”

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Registry EUDAMED 3 FDA 510(k) incl. De Novo FDA PMA GUDID

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Poland 2 Ireland 1

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

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Class A Class B Class C Class D IVD General 3 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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α-fetoprotein (AFP) Diagnostic Kit (Immunochromatographic Assay)

Shenzhen Microprofit Biotech Co., Ltd,China Group of variants

Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General
Diagnostic Kit for Alpha-fetoprotein (AFP) (Time-resolved Fluorescence Immunochromatographic Assay)

Shenzhen Superbio Technology Co., Ltd.,China

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

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