125mL HDPE Narrow Mouth Bottle
Perfect for sample storage
Development and product launch

Diagnosticgrade – because RUO and IVDR do not fit together

This unique quality seal ensures high quality and performance of raw materials ideally suited for use in development projects for IVD

With the DiagnosticGrade seal, the partners Johner Institut and myPOLS Biotec combine high-quality products, including reliable and reproducible product performance and knowledge on product verification procedures, including documentation to meet the requirements of the IVDR:

• IVD manufacturers can obtain reagents developed and produced by myPOLS Biotec under ISO 13485.
• We offer you the quality and safety that the IVDR requires from suppliers – these are, for example, control of suppliers via quality assurance agreements, information about changes, consent to audits.
• The Johner Institute provides  structured templates for the documentation of your product verification with clear and brief explanations of how to complete them.

Both cooperation partners express with the DiagnosticGrade seal that the reagents meet the relevant requirements and thus ensure the maturity level for diagnostics.

Diagnsoticgrade facilitates the development of new IVD assay products for IVD manufacturers and enables IVDR compliance of existing kits.

Please find more information on www.diagnosticgrade.de (in german) or contact us directly. About the Johner Institut: https://www.johner-institut.de

With the DiagnosticGrade seal, the partners Johner Institut and myPOLS Biotec combine high-quality products, including reliable and reproducible product performance and knowledge on product verification procedures, including documentation to meet the requirements of the IVDR:

Overview

• Detection kits for the EBV
• CE-IVD marked version available for in vitro diagnostic use
• Available in TaqMan format for analysis

Epstein-Barr Virus (EBV) is a member of the Herpes family of virus and is one of the most common viruses in humans. The virus occurs globally and causes infectious mononucleosis. Most individuals become infected with EBV and develop adaptive immunity, with the majority of adults between the ages of 35 and 40 having been infected. The virus has been implicated as having a primary role in multiple autoimmune diseases, several lymphoproliferative disorders and cancers, particularly Hodgkin’s disease and Burkitt’s lymphoma. Many children become infected with EBV once maternal antibody protection disappears, however these infections usually do not result in symptom development. During adolescence the virus will cause mononucleosis in up to 69% of infections

EBV TaqMan PCR Kit, 100 reactions

• Ready to use format, including Master Mix for the target and PCR control to monitor for PCR inhibition and validate the quality
• Specific Primer and Probe mix for the pathogen/virus/viroid of interest
• Primer and Probe mix
• Positive and negative control to confirm the integrity of the kit reagents

EBV TaqMan PCR Probe/Primer Set and Controls, 100 reactions

• Specific Primer/Probe mix and Positive Control for the pathogen/virus/viroid of interest
• Nuclease-free water
• Can be used together with Norgen’s PCR Master Mix (#28007) or customer supplied master mix

Details

Supporting Data

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Storage Conditions and Product Stability
All kit components can be stored for 2 years after the date of production without showing any reduction in performance.

All kit components should be stored at -20°C upon arrival. Repeated thawing and freezing (> 2 x) of the Master Mix and Positive Control should be avoided, as this may affect the performance of the assay. If the reagents are to be used only intermittently, they should be frozen in aliquots.