DSM Nutritional Products AG Zweigniederlassung Pentapharm

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Plasma, Coagulation Control (GGN) (1) Test, Time, Partial Thromboplastin (GGW) (1)

Premarket Exempt

Clear

Pefakit - 07640175460013 Catalog Number : 502-02

Device Description : Plasma based functional assay for the determination of resistance to activated p Plasma based functional assay for the determination of resistance to activated protein C caused by the Factor V Leiden mutation (FV:Q506).

Device Class : 2

Duns Number: 484563742

Premarket Exempt : No

Product Code : GGW

Prescription Use : Yes

Device Count : 1

Pefakit - 07640175460020 Catalog Number : 502-22

Device Description : Control plasma for assays aimed to determine the functional phenotype for activa Control plasma for assays aimed to determine the functional phenotype for activated protein C resistance caused by the Factor V Leiden mutation (FV:Q506).

Device Class : 2

Duns Number: 484563742

Premarket Exempt : No

Product Code : GGN

Prescription Use : Yes

Device Count : 1

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