Medical devices for COVID-19 are nowadays challenged by unparalleled market and compliance demands. Keeping up with these regulations from Asian manufacturers and other unique aspects of the Asia market requires profound experience, understanding and trustworthy suppliers.
The human cost of COVID-19 rises the global pandemic and radically alter our lives. This is where Ypsilon Solutions comes in. With a vast experience in the medical device industry and sourcing in Asian markets, Ypsilon can be of great help in all stages to purchase medical devices for COVID-19. We also include advisory services for market research, product regulation and medical device consulting.
In an effort to prevent the spread of COVID-19, Ypsilon offers both public administration and private organisations to purchase Real-Time PCR Kits and Extraction Systems, from manufacturers which comply with CE Marking to be legally commercialized in EU member states.
We also provide consultancy and advisory services for other prevention and safety products in the healthcare and medical device industries, working restlessly to protect and prevent the safety and health of the whole community, and thereby mitigating the economic damage.
REAL-TIME PCR KITS
Ypsilon has distribution agreements to commercialize in-vitro diagnostic (IVD) equipment, with direct sourcing channels of Real-Time Detection kits for rapid identification and detection of novel coronavirus (2019-nCoV).
Real-Time RT-PCR Kit is an in-vitro diagnostic kit that helps diagnose COVID-19. This kit is designed for the detection of SARS-CoV-2 (E gene and RdRp gene) RNA from a COVID-19 suspected patient’s sample such as sputum, nasopharyngeal swab, oropharyngeal swab through Real-Time Polymerase chain reaction (PCR).
PCR tests are used to directly detect the presence of an antigen, rather than the presence of the body’s immune response, or antibodies. By detecting viral RNA, which will be present in the body before antibodies form or symptoms of the disease are present, the tests can tell whether or not someone has the virus very early on.
MOLECULAR DIAGNOSTIC SYSTEMS
Companies interested in purchasing Real-Time PCR tests should realize they must be equipped with Molecular Diagnostic Systems for the workflow, which includes:
• Sample Preparation
• RNA Extraction
• PCR Preparation
• Real-time PCR
These devices require CE Marking, a certificate which indicates that an IVD device complies with the European In-Vitro Diagnostic Devices Directive (98/79/EC) and that the device may be legally commercialized in the EU.
Success in molecular diagnostic detection and analysis requires effective method in the nucleic acid extraction from various sample types. For that, Ypsilon works with a number of suppliers that offer CE marked Extraction Systems, in compliance with the regulatory requirements for IVDs.
Nucleic Acid Extraction Kit series provide a convenient and efficient method for the isolation and purification of nucleic acids from a variety of samples including blood, urine, sputum, BAL, swabs and so on.
Ipsilon Solutions has a team of expert consultants that has already assisted and worked with international clients of the healthcare industry.
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For urgent orders please contact directly our Healthcare Sales Director Pablo Garrido at +34 641 280 108
Torre Europa, P. de la Castellana, 95, Planta 15, Madrid, Madrid 28046, Spain