In Vitro Diagnostic (IVD) Products - Illumina
Designed, validated, and regulated for clinical use, Illumina diagnostic (IVD) products include sequencing instruments, assays, library prep kits, and software. The first CE-marked IVD …
List of Cleared or Approved Companion Diagnostic Devices
2025年1月21日 · A companion diagnostic device can be in vitro diagnostic (IVD) device or an imaging tool that provides information that is essential for the safe and effective use of a...
In Vitro Diagnostics | FDA
2024年11月13日 · In vitro diagnostics (IVD) are tests done on samples such as blood or tissue that have been taken from the human body. In vitro diagnostics can detect diseases or other …
IVD人必须知道的关于IVD试剂的50件事，你知道吗 - 知乎
答：依照我国2014年发布的 《体外诊断试剂注册管理办法》，按医疗器械管理的体外诊断试剂（IVD），包括在疾病的预测、预防、诊断、治疗监测、预后观察和健康状态评价的过程中， …
体外诊断（IVD）产品 - Illumina
一款CE认证的IVD套状解决方案，适用于多种实体瘤类型的DNA和RNA变体（外加MSI和TMB）全面基因组图谱分析（CGP）。 符合欧盟IVDR 2017/746号法规要求且可扩展的全基因组测序 …
IVD - Generi Biotech
We are an EN ISO 13485 certified EU-located company developing and producing CE IVD real-time PCR kits. Our in vitro diagnostics fall into five categories: clinical genetics, hematology, …
MiSeqDx Reagent Kit v3 | CE-marked IVD sequencing reagent kit
The MiSeqDx Reagent Kit v3 is an FDA-regulated Class I and CE-marked in vitro diagnostic (IVD) sequencing kit issued with a certificate of analysis, which labs can use to satisfy regulatory …
MiSeqDx v3试剂盒 | CE认证的IVD测序试剂盒 - Illumina
MiSeqDx v3试剂盒 经验证的、经FDA批准和CE认证的IVD测序试剂盒，能提供比之前版本更高的质量分值。
QXDx Products for In Vitro Diagnostics (IVD) | Bio-Rad
The QXDx product family for in vitro diagnostics (IVD) is a set of Droplet Digital PCR (ddPCR) tools — including an open mode system, universal reagents, and assay-specific kits — for …
Understanding an In Vitro Diagnostric kit - MedTech Europe
2015年7月23日 · In vitro diagnostic (IVD) test kit consists of materials used to determine the outcome of a given test. Laboratories use a variety of methodologies to test the countless …