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Dextramer CMV Kit

FDA UDI

Class II (US FDA UDI)

by Immudex ApS

Identity

Trade Name
Dextramer CMV Kit FDA UDI
Generic Name
T lymphocyte IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) FDA UDI
Device Name
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. FDA UDI
Model / Reference
CX02 FDA UDI
Description
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. FDA UDI

Identifiers

Catalog Number
CX02 FDA UDI
Primary DI / UDI-DI
05714183000010 FDA UDI
510(k) Number
K153538 FDA UDI
FDA Product Code
GKZ FDA UDI
GMDN Term
T lymphocyte IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.5220 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: T lymphocyte IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)

Dextramer CMV Kit by Immudex ApS — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as T lymphocyte IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Immudex ApS

Sources (1)

  • FDA UDI e64b7eba-1dc7-4037-ad51-857d0fd266d1 37 fields · synced May 30, 2026