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MHC Dextramer

FDA UDI

Class I (US FDA UDI)

by Immudex ApS

Identity

Trade Name
MHC 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. MHC Dextramer® reagent recognizing T cell receptors displayed on surface of human T cells restricted by HLA-A*11:01 with specificity for the KRAS G12V neopeptide: VVGAVGVGK. MHC Dextramer reagents consist of a dextran polymer backbone carrying an optimized number of MHC-peptide complexes and fluorochrome molecules (PE). MHC Dextramer reagents are provided in buffer containing 1% bovine serum albumin (BSA) and 15 mM NaN3, pH 7.2. FDA UDI
Model / Reference
HLA-A*1101 / VVGAVGVGK / PE FDA UDI
Description
Analyte specific reagent. Analytical and performance characteristics are not established. MHC Dextramer® reagent recognizing T cell receptors displayed on surface of human T cells restricted by HLA-A*11:01 with specificity for the KRAS G12V neopeptide: VVGAVGVGK. MHC Dextramer reagents consist of a dextran polymer backbone carrying an optimized number of MHC-peptide complexes and fluorochrome molecules (PE). MHC Dextramer reagents are provided in buffer containing 1% bovine serum albumin (BSA) and 15 mM NaN3, pH 7.2. FDA UDI

Identifiers

Catalog Number
WD05109A PE 50 FDA UDI
Primary DI / UDI-DI
05714183000133 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

Yes

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)

The MHC Dextramer reagent is a specialized immunological test used for detecting T cell receptors displayed on the surface of human T cells. It consists of a dextran polymer backbone carrying an optimized number of MHC-peptide complexes and fluorochrome molecules, providing sensitive and specific fluorescence. The MHC Dextramer reagents are designed to recognize and bind to specific antigens, such as KRAS G12V neopeptide, allowing for accurate analysis in clinical specimens.

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 bbf5bfd6-7bc5-4b41-990b-78866259600d 36 fields · synced Jul 2, 2026