Dextramer CMV Kit - The Dextramer® CMV Kit comprises :;HLA-A*0101 / - Immudex ApS

Duns Number:312388361

Device Description: The Dextramer® CMV Kit comprises :;HLA-A*0101 / VTEHDTLLY / PE; HLA-A*0201 / NLVPMVATV / P 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.

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More Product Details

Catalog Number

CX02

Brand Name

Dextramer CMV Kit

Version/Model Number

CX02

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K153538

Product Code Details

Product Code

GKZ

Product Code Name

Counter, Differential Cell

Device Record Status

Public Device Record Key

e64b7eba-1dc7-4037-ad51-857d0fd266d1

Public Version Date

November 08, 2018

Public Version Number

1

DI Record Publish Date

October 08, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"IMMUDEX APS" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1