DiaMex GmbH

About DiaMex

DiaMex is a provider of manufacturer-independent quality controls (3rd Party Controls) for in-vitro diagnostics. The portfolio includes the liquid serology controls of the Optitrol series for blood banks, classic childhood diseases and ToRCH, as well as NAT controls and multi-allergy controls since 2020. The ready-to-use products are optimized for common analysis platforms such as Abbott Architect, DiaSorin LIAISON and Roche Elecsys/Cobas and are supplied in platform-matched, barcoded tubes with very low dead volume. As far as technically possible, the controls are produced with human starting material, which is provided via the sister company Biomex with its own plasma centers in Germany and Africa; in this way, the controls can be manufactured batch-consistently close to patient material. The offering is complemented by access to the cloud-based QC monitoring software EDCNet™ with the QConnect™ concept, developed at the National Research Laboratories (NRL) in Australia. The portfolio is distributed in selected countries via an international distribution partner network.

Site

Heidelberg

Processes

Manufacturer-independent quality controls (3rd Party Controls) for in-vitro diagnostics, Serological controls (Optitrol) for blood banks, childhood diseases, ToRCH, NAT controls (since 2020), Multi-allergy controls, Ready-to-use controls with platform-matched, barcoded tubes, Access to cloud-based QC monitoring software EDCNet™ / QConnect™

Materials

Serological Controls, NAT Controls, Multi-Allergy Controls, Human Plasma and Sera

Certificates

Batch-specific QC certificates

Industries

In-vitro Diagnostics, Medical Laboratories, Blood Transfusion Centers, Blood Banks, Plasma Centers, Central Laboratories

1. 01

   Procurement of human starting material (plasma/sera via sister company Biomex)

2. 02

   Manufacturing of controls close to patient material

3. 03

   Filling into platform-matched, barcoded ready-to-use tubes

4. 04

   Quality control with QC certificates per batch

5. 05

   Distribution via international partner network

6. 06

   QC monitoring via EDCNet™/QConnect™

Product Lines and Raw Material

Locations

Heidelberg

DE

Registered office of the company

Berlin

DE

Location (TGS Haus 8, Ostendstraße 25)

Products

Inside the production

Quality

QC certificates (Quality Control Certificates) are published per batch for the products. The controls themselves serve to verify the testing accuracy of laboratory systems.

History

1. Seit über

   Offering of serological controls

2. 2020

   Expansion of the portfolio with NAT controls