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Results for “SARS-CoV-2 IgM (CLIA)”

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Registry EUDAMED 8 FDA 510(k) incl. De Novo FDA PMA GUDID

Country / market European Union (all) 8

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Germany 6 Netherlands 2

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 8 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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8 devices foundsorted by relevance

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Anti-SARS-CoV-2 IgM AccuLite CLIA Kit - 96 wells

Monobind, Inc.,United States

Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General
Anti-SARS-CoV-2 IgM AccuLite CLIA Kit - 192 wells

Monobind, Inc.,United States

Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General
SARS-CoV-2 IgM (CLIA)

Maccura Biotechnology Co., Ltd.,China Group of variants

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

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