Diagnosticgrade – because RUO and IVDR do not fit together
Facebook
X
Pinterest
Email
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:
Detail
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.
【Material】The vial storage box is made of durable cardboard with waterproof coating and cardboard dividers；chemically resistant to alcohols and mild organic
【Temperature Range】These freezer boxes are stable from -196°C to 121°C
【Applications】The freezer box is suitable for iquid nitrogen freezing (vapor phase)
【Capacity】Size: Height of 2 inch, Holds 0.5ml, 1.5ml, 2.0ml tubes
【Excellent Cusomer Service】We are dedicated in providing the best products and services to customers. If you have any problem, please feel free to contact us. We will help you solve the problem as soon as possible.
Document
【Material】The vial storage box is made of durable cardboard with waterproof coating and cardboard dividers；chemically resistant to alcohols and mild organic 【Temperature Range】These freezer boxes are stable from -196°C to 121°C 【Applications】The freezer box is suitable for iquid nitrogen freezing (vapor phase) 【Capacity】Size: Height of 2 inch, Holds 0.5ml, 1.5ml, 2.0ml tubes 【Excellent Cusomer Service】We are dedicated in providing the best products and services to customers. If you have any problem, please feel free to contact us. We will help you solve the problem as soon as possible.
Cell Culture Media Exosome Purification and RNA Isolation Kits
Product Info
Document
Product Info
Overview
Purification and enrichment of intact cell culture media exosomes for functional studies
Isolate all sizes of RNA, including microRNA, irrespective of size or GC content, without bias.
Versatile cell culture media input volumes
No phenol extractions, Proteinase K treatment, nor carrier RNA required
No time-consuming ultracentrifugation, filtration nor special syringes required
No precipitation reagents nor overnight incubation required
Pure exosomes are purified and are free from any other RNA-binding proteins
Purification is based on spin column chromatography that uses Norgen’s proprietary resin
The purified RNA is suitable for a variety of downstream applications, including Small RNA Sequencing. Find out more information on Norgen’s NGS services
Norgen’s Cell Culture Media Exosome Purification and RNA Isolation Kits constitute an all-in-one system for the purification of exosomes and the subsequent isolation of exosomal RNA from different cell culture media sample volumes. The purification is based on spin column chromatography that employs Norgen’s proprietary resin. The kit is designed to isolate all sizes of RNA, including microRNA, irrespective of size or GC content, without bias. These kits provide a clear advantage over other available kits in that they do not require any special instrumentation, protein precipitation reagents, extension tubes, phenol/chloroform or protease treatments. Moreover, the kits allow the user to elute into a flexible elution volume ranging from 50 µL to 100 µL. The RNA isolated from the purified exosomes is free from any protein-bound circulating RNA and is of the highest integrity. The purified RNA can be used in a number of downstream applications including real time PCR, reverse transcription PCR, Northern blotting, RNase protection and primer extension, and expression array assays.
Cell Culture Media Exosome Purification and RNA Isolation Mini Kit
For sample input volumes ranging from 5 mL to 10 mL.
Cell Culture Media Exosome Purification and RNA Isolation Midi Kit
For sample input volumes ranging from 10 mL to 20 mL.
Cell Culture Media Exosome Purification and RNA Isolation Maxi Kit
For sample input volumes ranging from 20 mL to 35 mL.
* Please check page 4 of the product insert for Average Yields and Common RNA Quantification Methods
Storage Conditions and Product Stability All buffers should be kept tightly sealed and stored at room temperature. This kit is stable for 2 years after the date of shipment. It is recommended to warm Lysis Buffer A for 20 minutes at 60°C if any salt precipitation is observed.
CE-IVDR marked in accordance with the European Commission Regulation (EU) No. 2017/746.
Ideal for use in in vitro diagnostic workflows
Simultaneous isolation of both host RNA and microbial RNA (universal protocol)
Isolate full diversity of RNA from large RNA down to small and microRNAs
Eliminates PCR inhibitors including humic acids
High quality RNA for sensitive downstream applications
This kit provides a convenient and rapid method to purify total RNA from small amounts of stool samples. All types of stool samples can be processed with this kit, including animal fecal samples, manure and samples collected using Norgen’s Stool Nucleic Acid Collection and Transport Devices Dx (Cat. Dx45660). The kit removes all traces of humic acids using rapid and simple spin column procedures. Bead tubes are also provided for effective homogenization of stool. The kit purifies all sizes of RNA, from large mRNA and ribosomal RNA down to microRNA and small interfering RNA. Both host and microbial RNA is recovered. The protocol does not rely on the use of phenol or chloroform, thereby providing a user friendly procedure and allowing high-throughput analysis. The purified RNA is of the highest integrity, and can be used in a number of downstream applications including real time PCR and reverse transcription PCR for gene expression analysis. The procedure can be completed in approximately 30 minutes.
NOTE: This product is not available for sale in the United States.
Storage Conditions and Product Stability All solutions should be kept tightly sealed and stored at room temperature. This kit is stable for 2 years after the date of shipment.
