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CMV Dextramer

FDA UDI

Class I (US FDA UDI)

by Immudex ApS

Identity

Trade Name
CMV Dextramer FDA UDI
Generic Name
T lymphocyte IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) FDA UDI
Device Name
Analyte specific reagent. Analytical and performance characteristics are not established. CMV Dextramer reagents react with T cell receptors on human CD8+ T cells restricted by the HLA allele of the Dextramer and specific for the CMV peptide displayed. CMV Dextramers comprise dextran polymer backbone carrying multiple fluorochrome molecules (PE) and multiple MHC-peptide complexes displaying a peptide epitope from a CMV antigen. CMV Dextramer reagents are provided in liquid form in volumes of 0,5 ml in buffer containing 1% bovine serum albumin (BSA) and 15 mmol/L NaN, pH 7.2. FDA UDI
Model / Reference
HLA-A*0301 / KLGGALQAK / PE FDA UDI
Description
Analyte specific reagent. Analytical and performance characteristics are not established. CMV Dextramer reagents react with T cell receptors on human CD8+ T cells restricted by the HLA allele of the Dextramer and specific for the CMV peptide displayed. CMV Dextramers comprise dextran polymer backbone carrying multiple fluorochrome molecules (PE) and multiple MHC-peptide complexes displaying a peptide epitope from a CMV antigen. CMV Dextramer reagents are provided in liquid form in volumes of 0,5 ml in buffer containing 1% bovine serum albumin (BSA) and 15 mmol/L NaN, pH 7.2. FDA UDI

Identifiers

Catalog Number
WC02197A PE 50 FDA UDI
Primary DI / UDI-DI
05714183000058 FDA UDI
FDA Product Code
MVU FDA UDI
GMDN Term
T lymphocyte IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.4020 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

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

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)

CMV Dextramer by Immudex ApS — Class I — 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 febf1968-3ac4-4726-b267-476e554b8926 36 fields · synced May 31, 2026