Immudex ApS

Address:Bredevej 2A,Virum Hovedstaden,DK

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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

Counter, Differential Cell (GKZ) (1)

Premarket Exempt

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Dextramer CMV Kit - 05714183000010 Catalog Number : CX02

Device Description : The Dextramer® CMV Kit comprises :;HLA-A*0101 / VTEHDTLLY / PE; HLA-A*0201 / NLV The Dextramer® CMV Kit comprises :;HLA-A*0101 / VTEHDTLLY / PE; HLA-A*0201 / NLVPMVATV / PE; HLA-B*0702 / TPRVTGGGAM / PE; HLA-B*0801 / ELRRKMMYM / PE;HLA-B*3501 / IPSINVHHY / PE Negative control / PE; Anti-CD8/FITC; Anti-CD3/PerCP; Anti-CD4/PE The Dextramer CMV Kit accurately enumerates CMV-specific T cells in blood samples. Dextramer® CMV Kit is a semi-quantitative assay intended for the identification and enumeration of cytomegalovirus (CMV)-specific CD8+ T cells in anticoagulated (Na Heparin) whole blood specimens by flow cytometry. Dextramer® CMV Kit is indicated for assessment of CMV-specific immune status and risk of CMV reactivation in adult human stem cell transplant patients following immunosuppression and used in conjunction with other laboratory and clinical findings. The kit cannot be used to measure CMV infection or disease.

Device Class : 2

Duns Number: 312388361

Premarket Exempt : No

Product Code : GKZ

Prescription Use : Yes

Device Count : 1

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