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Tag Archives: IVD

Roszdravnadzor issued the first permission to use an unregistered medical device for in vitro diagnostics.

Posted on Thursday May 4th, 2023 by beawireA

As part of the implementation of Decree of the Government of the Russian Federation No. 2026 dated November 24, 2021 “On unregistered medical devices for in vitro diagnostics”, Roszdravnadzor for the first time issued permission for the use of an unregistered medical device for in vitro diagnostics “A kit of reagents for high-throughput sequencing of human biological material in order

IVD regulation

Fluorescence in situ hybridization – FISH test

Posted on Friday October 28th, 2022 by beawireA

In Russia, there is a risk of disappearance of tests for genetic breakdowns and oncological diseases. According to information from some laboratories, there is a risk of stopping the so-called FISH studies. It can happen because the American manufacturer of equipment, reagents, consumables, and software Thermo Fisher Scientific left the country. Fluorescence in situ hybridization (FISH) is a molecular cytogenetics

Medicaldevices

Toxicology tests for in vitro diagnostics

Posted on Monday August 17th, 2020 by beawire

Toxicology tests for medical devices intended for in vitro diagnostics are to be performed in order to determine any possible harmful effect of a material or device on the human body, caused by a toxicity factor. These tests have to be performed for medical devices intended for immediate contact with the human body, when used as per the intended indications

Immunochemiluminescent analysis as a diagnostic method

Posted on Monday June 29th, 2020 by beawire

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

IVD regulation

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

Posted on Tuesday June 16th, 2020 by beawire

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

Technical testing of medical devices for in vitro diagnostics

Posted on Tuesday April 14th, 2020 by beawire

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

IVD regulation

Registration procedure for medical devices for in vitro diagnostics

Posted on Wednesday April 8th, 2020 by beawire

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)

IVD regulation

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

Posted on Tuesday April 7th, 2020 by beawire

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

IVD regulation

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

Posted on Monday November 18th, 2019 by beawire

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

IVD regulation

In vitro diagnosis of autoimmune diseases

Posted on Thursday October 3rd, 2019 by beawire

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

Medicaldevices

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