Tag Archives: ivd

Immunochemiluminescent analysis as a diagnostic method

Currently, there are many models of automatic analyzers that differ in the method used to detect the desired substance. The main analysis methods used are: – radioimmunological (RIA); – enzyme-linked immunosorbent assay (ELISA); – Immunofluorescence; – immunochemiluminescent; – immunochromatographic; – isoserological. Let us consider in more detail immunochemiluminescent analysis. Immunochemiluminescent analysis is based on the enzyme immunoassay. The principle of

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Free consultations (products intended to be used for coronavirus infection diagnostics)

Since March 20, 2020, due to the need to take measures for the non-proliferation of the Coronavirus infection (2019-nCoV), the Federal Service for Surveillance in the Sphere of Health of the Russian Federation (Roszdravnadzor or RZN) introduces special rules. These rules concern consultations about the registration of medical devices intended for the diagnosis of coronavirus infection (consultations in accordance with

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Technical testing of medical devices for in vitro diagnostics

According to the Government of the Russian Federation decree dated 27 December 2012 No. 1416 “On the approval of the rules state registration of medical devices” the term “technical testing” is defined as the testing to determine whether the characteristics (properties) of the medical device meet the requirements of the regulatory, technical and operational documentation of the producer (manufacturer) and

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Registration procedure for medical devices for in vitro diagnostics

A medical device for in vitro diagnostics is any medical device intended by the manufacturer to study samples of human biological material without contact with a patient in separate application or in combination with other medical devices, only for the purpose of obtaining regarding physiological or pathological condition, and (or) fetal development problems, and (or) monitoring therapeutic interventions, and (or)

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Urgent registration process for Covid-19 tests is approved by Government

  Order of Russian Government 430 from 03th of April 2020 was published yesterday (06th of April 2020), what is inside: list of products intended to be used in special conditions (emergency, martial law and so on). In this list – IVD test for COVID-19, thermometers, artificial ventilator apparatus; registration certificate is issued on the base on series/LOTs of medical

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THE IMPACT OF POTENTIALLY INTERFERING SUBSTANCES ON THE RESULTS OF CLINICAL LABORATORY TESTS

The reliability and accuracy of the sample results in clinical laboratory tests are influenced by many factors, such as the preanalytical factor, sampling, transportation, storage of samples, as well as the presence of interfering substances in the biomaterial samples. Interfering substances are one of the most common errors in clinical laboratory measurements. The presence of these substances in the samples

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In vitro diagnosis of autoimmune diseases

Autoimmune diseases (AID) develop in cases where antibodies (AT) or T cell clones are present in the body, directed against the body’s own antigens (AG). Autoimmune mechanisms are at the heart of many organo-specific and systemic diseases.  These diseases include rheumatoid arthritis, insulin-dependent diabetes mellitus, ulcerative colitis and other less known diseases. The resulting autoimmune process is usually chronic and

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Preclinical trials, registration process in Russia – seminar

Seminar for Korean manufacturers contains information about: how to be prepared for technical and toxicological trials (preclinical trials) during Russian registration? what is main feature? does Russian Government have list of applied standards for medical devices nowadays? how to provide trials of IVD? How registration process is provided and what is the place of trials in this process.

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