First 500,000 InTec’s rapid tests arrived in Europe

ProDiag BV has received its first shipment of 500,000 of InTec’s SARS-CoV-2 IgM/IgG antibody rapid tests!

Next shipments are lined up. It shows China’s NMPA and Ministry of Commerce have stepped up their role in granting export licenses for validated products only.

We base our Instructions For Use on a study performed at the CDC in Wuhan (n=454), resulting in a 94,4% sensitivity and 98% specificity. We are actively pursuing to add more data to this dataset.

InTec has been a specialized manufacturer of rapid tests in infectious diseases for 30 years and had 2 other rapid tests (HIV and HCV) succesfully pass the WHO Pre-Qualification program. This means that technical files, quality system and production sites have passed WHO teams’ audits.

We strongly believe launching products should be done in a responsible way. InTec’s test has therefore been entered into evaluations at China CDC locations, FIND, US FDA EUA, Erasmus Medical Center, RIVM, WHO EUL and many others.

Although interim reports on partial data sets are circulating, full study reports will come out soon.

This test is delivered to medical professionals and sub-distributors only.

www.prodiag.nl

www.prodiag.nl/store/rapid-sars-cov-2-antibody-igm-igg-test-25-pieces/

We are proud to contribute in the fight against COVID19!

#Corona #antibody #serology #ivd #virology

ProDiag opens new offices and warehouse in Soest and welcomes new staff

Under normal circumstances a very lively event, but under COVID19 conditions we have proudly yet silently opened our new offices and warehouse in Soest.

We will be remodelling the office spaces and set up a demo lab for our Corona rtPCR solutions and other products.

At the same we welcome

  • Mark de Jong as our Manager Operations
  • Nigel de Jong as Assistant Manager Operations
  • Elvera Keurhorst as Product Specialist PCR
  • Ronald Warmerdam as Sales Manager

 

ProDiag has been contracted as InTec’s Sales Representative in Europe

ProDiag and Intec (Xiamen, China) have agreed that ProDiag will act as their exclusive sales representative in Europe.

ProDiag will seek local sub-distributors to cover the territory.

InTec is a manufacturer of high quality tests for  e.g. infectious diseases.

It has received WHO PreQualification status for its HIV and Hepatitis C rapid tests in 2019.

This means the company’s Quality System and Production Sites have passed what is considered to be the toughest review and audit process in the world.

 

POC Blood Grouping test HemoGroup M now comes with CE certificate

Order now, delivery within couple of weeks

EC Certificate No. 1434-IVDD-040/2020

ProDiag signs a distribution agreement with CTK Diagnostics from CA, USA

ProDiag has signed a distribution agreement with CTK Diagnostics in order to complete its professional point-of-care testing range in the Benelux.

Products to be added will be tests for e.g Influenza A/B, Syphilis, Herpes and Strep A.

ProDiag and ISO 13485:2016

ProDiag has initiated a project together with CEPartner4U to establish a quality system according to the ISO standard 13485:2016.

This process is planned to be completed in mid 2020, making ProDiag a certified distributor well ahead of time to comply with new IVDR requirements.

ProDiag is now supplying the Vein Navi® Illuminator

The NAVI-60 Vein Illuminator privdes a real time accurate image of vasculature on the surface of the skin, which helps clinicians to verify the status of the veins and reduces risk of venipuncture.

 


 

MedCaptain and ProDiag sign a distribution agreement for HaemaT4 (hemostasis) in Benelux

MedCaptain Europe B.V. and ProDiag B.V. have signed a first exclusive agreement covering the Benelux for the IVD hemostasis product line: HaemaT4.

The HaemaT4 provides thromboelastography data, giving a full picture on clot formation (coagulation) and dissolving of the clot (fibrinolysis).

ProDiag and MedCaptain will explore additional territories to work in together.

We look forward to building this product line into a big success.

MedCaptain’s vein illumination product Vein Navi will also be distibuted by ProDiag.

 

 

ProDiag launches NanoRepro products in the Benelux region

ProDiag is promoting the NanoRepro product range in the Benelux:

  • allergy: milk, gluten, and a combo test for house dust, pollen and hair
  • fertility: ovulation LH, pregnancy HCG and sperm count tests
  • menopauze test FSH
  • other: Ferritin, TSH, alcohol, helicobacter C

First customers have started measuring ketone concentrations

With certain diets, inducing ketosis is an explicit goal. In such cases, it makes sense to verify IF ketosis has been induced, and if it still within safe levels, before ketoacidosis (< 8 mmol/l). Our customers have started to gain experience in measuring from finger prick whole blood with our reader.