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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 (APC). 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 / APC 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 (APC). 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 AP 50 FDA UDI
Primary DI / UDI-DI
05714183000126 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)

MHC 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 c55df382-c05c-4836-92b0-b4eaea37fd94 36 fields · synced May 29, 2026