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.
This product provides fast and easy methods for purification of total DNA for reliable PCR and southern blotting. Total DNA can be purified from bacterial culture, body fluids, food and fermentation.
Details
Specifications
Features
Specifications
Main Functions
Isolation bacterial DNA from cultures, food and other samples
Applications
PCR, southern blot and enzyme digestion, etc.
Purification method
Mini spin column
Purification technology
Silica technology
Process method
Manual (centrifugation or vacuum)
Sample type
Culture medium, swab, parasitic blood, tissue,sputum, etc.
Sample amount
Bacterial culture medium: 0.5-2 mlTissue samples: 50-100 mg Whole blood / cell suspension: 0.5-1 ml Viscous secretion: 0.1-1 g
Elution volume
≥30μl
Time per run
≤40 minutes
Liquid carrying volume per column
800μl
Binding yield of column
100μg
Principle
This product is based on silica Column purification. The sample is lysed and digested with lysate and protease, DNA is released into the lysate. Transfer to an adsorption column. Nucleic acid is adsorbed on the membrane, while proteinis not adsorbed and is removed with filtration. After washing proteins and other impurities, Nucleic acid was finally eluted with low-salt buffer (10mmTris, pH9.0, 0.5mm EDTA). This product carries 0.1-0.2mm acid glass beads, which can improve the wall-breaking effect of lysozyme resistant bacteria, the success rate and DNA yield through physical bead grinding.
Advantages
Fast – several samples can be extracted in 40 minutes (after digestion)
High purity – purified DNA can be directly used in various downstream applications
Good repeatability – silica technology can obtain ideal results every time
High recovery – DNA can be recovered at the level of PG
Broad spectrum – it can deal with a variety of bacteria, including Gram-positive bacteria that are difficult to disrupt
Sufficient components – this kit has carried lysozyme, protease K, RNase A and glass beads
Kit Contents
Contents
D314602
D314603
Purification Times
50 Preps
250 Preps
Hipure DNA Mini Columns I
50
2 x 125
2ml Collection Tubes
50
2 x 125
Glass Beads (0.1~0.2mm)
20 g
100 g
Buffer P1
20 ml
100 ml
Buffer DL
15 ml
80 ml
Buffer GW1
22 ml
88 ml
Buffer GW2
12 ml
50 ml
Lysozyme
60 mg
300 mg
Proteinase K
24 mg
120 mg
Protease Dissolve Buffer
5 ml
15 ml
Buffer AE
15 ml
60 ml
Storage and Stability
Lysozyme and Proteinase K should be stored at 2-8°C upon arrival. However, short-term storage (up to 12 weeks) at room temperature (15-25°C) does not affect their performance. The remaining kit components can be stored dry at room temperature (15-25°C) and are stable for at least 18 months under these conditions.
Document
This product provides fast and easy methods for purification of total DNA for reliable PCR and southern blotting. Total DNA can be purified from bacterial culture, body fluids, food and fermentation.
Propargyl-PEG4-CH2CO2-NHS has a propargyl group and an NHS group. This reagent is amine reactive, thus, useful for derivatizing biomolecules with amine group. The propargyl group reacts with azides via copper catalyzed azide-alkyne Click Chemistry to form stable triazole bond. Reagent grade, for research purpose. Please contact us for GMP-grade inquiries.
Document
Propargyl-PEG4-CH2CO2-NHS has a propargyl group and an NHS group. This reagent is amine reactive, thus, useful for derivatizing biomolecules with amine group. The propargyl group reacts with azides via copper catalyzed azide-alkyne Click Chemistry to form stable triazole bond. Reagent grade, for research purpose. Please contact us for GMP-grade inquiries.
KBA.62, also known as Melanoma Associated Antigen, is used to detect an antigen present in melanocytic tumors, such as melanomas, due to its proven sensitivity and specificity. The antibody can also be used to distinguish between junctional nevus and intradermal nevus cells, and fetal melanocytes versus normal adult melanocytes. Studies have shown KBA.62 to be highly useful in differentiating between metastatic amelanotic melanoma and a number of poorly differentiated carcinomas, large cell lymphomas, sarcomas, and spindle cell carcinomas.
