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Results for “Universal Sample Preparation Kit”

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Registry EUDAMED 2 FDA 510(k) incl. De Novo 1 FDA PMA GUDID

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Class A 2 Class B Class C 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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Universal Sample Preparation Kit

Xukang Medical Technology (Suzhou) Co., Ltd.,China Group of variants

Active Regimes: CE IVDR Registry: EUDAMED Class:A
BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5 optical configurations), BD FACSDuet Sample Preparation System, BD FACS Universal Loader, BD FACSuite Clinical software, BD Multitest 6-Color Assay Modules, BD Multitest 4-Color Assay Modules, BD FACSFlow Sheath Fluid, BD CS&T Beads, BD FC Beads 7-Color Kit Open recall

Becton, Dickinson and Company,United States

Active Regimes: 510(k) Registry: 510(k) Class:II

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