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...

2022年12月20日 · In vitro diagnostics (IVD) are tests or examinations conducted on samples retrieved from the human body such as blood or tissue samples. “In vitro”, meaning “in glass”, indicates that these tests are generally done using equipment like test tubes or petri dishes.

医学检验 最主要的样本类型—血液，因其组分的不同可以做不同的项目，那么全血、血清和血浆之间到底有什么区别呢？又分别适用于哪些ivd项目呢？ 血液的组成（1）血液有血细胞（红细胞、白细胞、血小板）和血浆组成…

2024年12月20日 · An overview of how the FDA regulates in vitro diagnostic products (IVD). Manufacturers can find detailed information about complying with the Federal, Food, Drug and Cosmetic Act (FD&C Act).

2020年2月10日 · In vitro diagnostics (IVDs) are tests that can detect disease, conditions and infections. In vitro simply means ‘in glass’, meaning these tests are typically conducted in test tubes and similar equipment, as opposed to in vivo tests, which are conducted in the body itself.

In this review, we address the major differences relating to marketing authorization and testing between this new Regulation and its predecessor. We further present the main elements of the prequalification assessment introduced by the WHO for IVDs, including disease-specific IVDs for blood screening laboratories.

There are donor screening tests, which are typically immunoassays. These could be enzyme immunoassays or more recently, the chemiluminescent immunoassays that have come to market, which detect...

2024年9月13日 · In vitro diagnostics are clinical tests that analyze biological samples, such as blood, fluid, or tissue. IVDs are a common tool in healthcare, used in detecting disease or infection, measuring the concentration of specific analytes, or monitoring individual patient health.

Its purpose is to assist a manufacturer to allocate its In Vitro Diagnostic (IVD) medical device to an appropriate risk class using a set of harmonized principles. Regulatory Authorities have the responsibility of ruling upon matters of interpretation for a particular medical device.

2022年9月11日 · 血细胞分析仪（Blood Cell Analyzer），又名血液细胞分析仪、 血液分析仪 （Hematology Analyzer）、血球仪、血球计数仪等，是对一定体积全血内细胞种类、数量和异质性进行自动分析的常规检验仪器。主要检测血液中的有形成分：红细胞、白细胞、血小板，以及红 …