Mentype® AMLplexQS PCR Amplification Kit is IVDR-certified!

12
.
Jun
2025
Share this post
Home
News
Home
News

Precision you can trust, now with full IVDR compliance!

We're proud to announce the IVDR re-launch of our optimized Mentype® AMLplexQS PCR Amplification Kit.

This advanced assay offers exceptional reliability and high precision for screening gene fusions in patients with suspected Acute Myeloid Leukemia, now fully aligned with EU Regulation 2017/746.

Elevate your AML diagnostics in a rapidly evolving landscape, where staying ahead means responsibility, reliability, and trust.

Subscribe to newsletter

Subscribe to receive the latest blog posts to your inbox every week.

By subscribing you agree to with our Privacy Policy.
Vielen Dank!
Oops! Something went wrong while submitting the form.

Related posts

9.3.2023

Another essential milestone on our IVDR journey!

We are thrilled about the designation of mdc medical device certification GmbH as the 9th EU-IVDR Notified Body.

4.4.2025

BIOTYPE is IVDR-certified!

After an intensive, almost two-year process, BIOTYPE GmbH has received the certificate for our quality management system and for our first IVDR products according to (EU) 2017/746!

15.4.2025

Advanced STR-Chimerism Analysis: Our Workflow is Now IVDR Compliant!

BIOTYPE is proud to reinforce its unwavering commitment to the highest quality and safety standards in molecular precision diagnostics. This achievement, through certification according to Regulation 2017/746 (IVDR), signifies our dedication to delivering cutting-edge solutions.

30.4.2025

Mentype® DIPscreen PCR Amplification Kit is IVDR-certified!

BIOTYPE achieves another IVDR milestone! We're thrilled to introduce Mentype® DIPscreen PCR Amplification Kit as a new INDEL-based tool for sensitive chimerism analysis after allogeneic hematopoietic stem cell transplantation (allo-HSCT) - now available in full compliance with IVDR (EU) 2017/746.

View all