Diagnosticgrade – because RUO and IVDR do not fit together
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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.
Magen’s HiPure columns are prepared by high quality glass fiber filter membrane as raw materials through membrane cutting, membrane release, ring release, ring pressing, gland, weighing and other processes. HiPure nucleic acid adsorption columns have the characteristics of long-term stability and high binding capacity. Experiments show that the highest binding capacity and binding efficiency of HiPure nucleic acid adsorption columns are basically unchanged when stored at room temperature for 4 years.
The series of nucleic acid columns produced by Magen Biotech are based on carefully selected imported glass fiber membranes (GF/B, GF/D, GF/F). Columns production processes such as polypropylene injection molding materials, injection molding process, and downstream membrane packing and compression rings are strictly controlled. This is to ensure that the column has extremely high adsorption capacity and long-term stability. Compared with conventional products on the market, Magen’s columns are with varieties, and binding rate will not change when stored at room temperature for 4 years.
Details
Specifications
Features
Specifications
Recommended application
gDNA medium yield preparation, total RNA medium yield preparation
Preservation conditions
Room temperature
Stability
Up to 4 years
Filter membrane
High quality glass fiber filter GF/B, 4 layers
Membrane aperture
1.0 μm
Maximum yield of alcohol mediated Binding
1 mg
Single liquid carrying capacity of column
4 ml
Minimum elution volume
500 μl
Withstand centrifugal force
3,000 – 5,000 x g
Centrifuge
Lowspeed centrifuge for 15ml centrifuge tubes, >3000 x g, swing-out Rotor, or Fixed Angle Rotor
Adsorption Mechanism
Based on the negatively charged DNA skeleton, it has a high affinity for positively charged glass fibers. In high salt and ethanol solutions, DNA/RNA binds to glass fiber and interacts with hydrophilic matrix on silica through hydrogen bond. DNA/RNA is tightly bound. All pollutants can be removed by washing solution. At high salt concentration, nucleic acids selectively bind to silica gel membrane, while other pollutants, mainly proteins, are removed by membrane washing.
Ordering information
CAT.No.
Product Name
Package
C13120
HiPure DNA Midi Column (4 x GF/B)with 15ml Collection Tubes
100/Bag
Purchase Guide
Item No.
Product Name
Membrane type/number of layers
Collection tubes
Plasmid DNA binding capacity (Physical adsorption)
Note: GF/B pore size is for 1.0μM glass fiber membrane; GF/F pore size is for 0.7μm glass fiber membrane.
Document
Magen’s HiPure columns are prepared by high quality glass fiber filter membrane as raw materials through membrane cutting, membrane release, ring release, ring pressing, gland, weighing and other processes. HiPure nucleic acid adsorption columns have the characteristics of long-term stability and high binding capacity. Experiments show that the highest binding capacity and binding efficiency of HiPure nucleic acid adsorption columns are basically unchanged when stored at room temperature for 4 years.
