Results for “CMV IgM CLIA Microparticles”

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Registry EUDAMED 3 FDA 510(k) FDA PMA GUDID

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

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Class A Class B Class C 3 Class D IVD General 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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CMV IgM CLIA Microparticles UDI-DI 06970150908812

Autobio Diagnostics Co., Ltd.,China

Active Regimes: CE IVDR Registry: EUDAMED Class:C
3 variants
- CMV IgM CLIA Microparticles CMK0203
- CMV IgM CLIA Microparticles CMK0205

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Results for “CMV IgM CLIA Microparticles”

Category (EMDN)

CMV IgM CLIA Microparticles UDI-DI 06970150908812