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Results for “Neutrophil Gelatinase-associated Lipocalin (NGAL) Control”

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Registry EUDAMED 5 FDA 510(k) incl. De Novo FDA PMA GUDID

Country / market European Union (all) 5

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Germany 4 Spain 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 5 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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Control For Neutrophil Gelatinase Associated Lipocalin (NGAL)

Chongqing iSIA BIO-Technology Co., Ltd.,China

Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General
Neutrophil Gelatinase-associated Lipocalin (NGAL) Control

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

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

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