In-vitro-Diagnostic Medical Device Regulation (IVDR) CE Certification IVDR (EU) 2017/746 The safety and quality of In-vitro-Diagnostics (IVDs) is becoming increasingly important as consumers demand the highest safety standards from suppliers of products and services in the healthcare sector. In...
体外诊断医疗器材InVitroDiagnosticDeviceIVD系指用於疾病.DOC,體外診斷醫療器材 (In Vitro Diagnostic Device, IVD) 係指用於疾病 或其他狀況之診斷,包括健康狀態之決定,以達治療、減緩或預防疾病或 其後遺症之目的所使用之診斷試劑、儀器與系統。該等產品係使用於蒐集
Intertek's expertise in In Vitro Diagnostic Devices can help accelerate your product development process and support critical stages of approval and certification
Privacy Policy Cookies Settings Organizational Model and Code of Ethics D.Lgs 231/2001 Legal Info Do Not Sell My Data The SCIEX clinical diagnostic portfolio is For In Vitro Diagnostic Use. Rx Only. Product(s) not available in all countries. For information on availability, please contact your...
Whether you’re designing a bench-top system for a physician’s office or a large-scale system for a clinical laboratory, Saint-Gobain Medical can help simplify the development of your In vitro diagnostic (IVD) device. Leveraging our deep materials expertise and application knowledge, we offer ...
advancing the plunger into the housing to pierce the one or more reagent pouches in the reagent region to cause reagent therein to be released and mix; inserting the test swab with obtained sample into the interior of the plunger; rotating the in vitro test device and disposing it on its pl...
A medical device is an in vitro diagnostic medical device (IVD) if it is a reagents, calibrator, control material, kit, specimen receptacle, software, instrument, apparatus, equipment or system, whether used alone or in combination with other diagnostic goods for in vitro use.According to the ...
Surmodics, Inc. is a leading provider of surface modification, drug delivery, and in vitro diagnostic technologies to the healthcare industry.
In Vitro Diagnostic Medical Device For in-vitro diagnostic use. Specifications subject to change. Availability of product in each country depends on local regulatory marketing authorization status. Not all products are available in all countries. Please consult your local sales...
The CE mark on your in vitro diagnostic device can also increase your competitiveness on the global market beyond EU nations. Our customers enjoy a single-source provider experience from around the world, and have access our network of highly qualified medical device experts sitting locally in majo...