Results for “SPOT-it TREC & SMN1 Screening Kit”

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Registry EUDAMED 4 FDA 510(k) incl. De Novo FDA PMA GUDID

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Sweden 3 Italy 1

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

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Class A Class B Class C 2 Class D IVD General 2 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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SPOT-it TREC, KREC & SMN1 Screening Kit

ImmunoIVD AB,Sweden Group of variants

Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General
SPOT-it TREC & SMN1 Screening Kit

ImmunoIVD AB,Sweden Group of variants

Active Regimes: CE IVDR CE IVDD Registry: EUDAMED Class:C

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Results for “SPOT-it TREC & SMN1 Screening Kit”

Category (EMDN)

SPOT-it TREC, KREC & SMN1 Screening Kit

SPOT-it TREC & SMN1 Screening Kit