Clinical-Grade Dextramer®

Excellence in Manufacturing and Beyond

Responsibility for manufacturing clinical-grade reagents does not end upon shipment

Ensuring high-quality in production, prior to release, and during use


Immudex stands behind every reagent produced with documented evidence of quality, batch consistency, and stability. 

Built into the Immudex Clinical-Grade Dextramer® reagents offering are multiple checks to ensure that every batch delivered is a robust, tailored component of a long-term strategy for immune monitoring.

MANUFACTURING

In accordance with
ISO 13485 and 21 CFR 820

IN-PROCESS QUALITY CONTROL

MHC-peptide integrity
Biotinylation degree
Monomer degradation

FINAL QUALITY CONTROL

MHC Dextramer® integrity

PRODUCT RELEASE

Labeling review
Batch record review
Certificate of Analysis provided

Quality that Meets Authoritative Standards and Requirements

Immudex Clinical-Grade Dextramer® reagents meet numerous requirements in accordance with quality system requirements for medical devices defined by ISO 13485 and 21 CFR 820 to be used as:

  • Components for laboratory-developed tests (LTD)
  • Reagents for medical devices governed by the Clinical Laboratory Improvement Amendments (CLIA), the US Food & Drug Administration (FDA), and the EU In Vitro Diagnostic Directive (IVDD)
  • Tools for clinical investigations in accordance with good clinical (laboratory) practice (GC(L)P) and in compliance with ethical principles of medical research involving human subjects as set forth by the Declaration of Helsinki
  • Materials in manufacturing and quality control of investigational and commercial pharmaceutical products in compliance with good manufacturing practices (GMP)

Order Clinical-Grade Dextramer® Reagents


Find a broad selection of already available Clinical-Grade Dextramer® reagents in the table below.
If you are interested in other specifications, please contact us at customer@immudex.com to process your request.
You can find a list of our current available MHC alleles.

To order your off-the-shelf Clinical-Grade Dextramer® reagent, please send an email to ordering@immudex.com specifying:

  • Cat. no
  • Test size (50, 150 tests)

Immudex has updated the catalog numbers. To learn more about it, please consult the document here

Cat. No.

Allele

Peptide

GB3247-PE

HLA-A*0201

SLLMWITQV

GB4198-PE

HLA-A*0201

KVLEHVVRV

GB2696-PE

HLA-A*0201 

SLLMWITQC

GB3578-PE

HLA-A*0201

GVYDGREHTV

GB3723-PE

HLA-A*0201

FMNKFIYEI

GB3474-PE

HLA-A*0201

KVLEYVIKV

GB3246-PE

HLA-A*0201

GLYDGMEHL

GB4074-PE

HLA-A*0201

SLLQHLIGL

GB2162-PE

HLA-A*0201

ELAGIGILTV

GB3429-PE

HLA-A*0201

WLSLLVPFV

GB4315-PE

HLA-A*0201

RMSAPSTGGV

GB4313-PE

HLA-A*0201

FLLDGSANV

GB3823-PE

HLA-A*0201

YMLDLQPET

GB2666-PE

HLA-A*0201

Neg. Control

GA2131-PE

HLA-A*0101

VTEHDTLLY

GB2132-PE

HLA-A*0201

NLVPMVATV

GC2197-PE

HLA-A*0301

KLGGALQAK

GF2133-PE

HLA-A*2402

QYDPVAALF

GH2135-PE

HLA-B*0702

RPHERNGFTVL

GH2136-PE

HLA-B*0702 

TPRVTGGGAM

GI2137-PE

HLA-B*0801

ELRRKMMYM

GK2138-PE

HLA-B*3501

IPSINVHHY

GI3233-PE

General

Neg. Control

 

Test Size 

Price (EUR)

Price (USD)

50 tests

1.600

1.850

150 tests

3.200

3.700