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About the rapid self-test of the new crown antigen Three types of people can test themselves:
Persons with respiratory symptoms, fever and other symptoms within 5 days of onset of symptoms; persons in home isolation observation, close contact and sub-close contact, entry isolation observation, closed control area and control area; residents who neRead more -
New crown antigen rapid self-test kit (part of products)
through saline solution, tiny gold nanoparticles and paper with antibodies, and a unique biochemical reaction – provides us with faster, more economical and more convenient and relatively accurate results (compared to nucleic acid testing, the reliabilityRead more -
what need to develop a compliance strategy under the IVDR?
what need to develop a compliance strategy under the IVDR? In order to develop a compliance strategy under the IVDR, the European Commission recommends that manufacturers do a gap analysis and action plan, including the following: Assess the impact of adaRead more -
New crown detection reagent/sample preservation solution/PCR machine CE certification process
When medical device products enter the European market, they often need to pass CE certification. The in vitro diagnostic medical device directive (in vitro diagnostic medical devices Directive (98/79/EC), hereinafter referred to as IVDD), which was origiRead more -
Manufacturers of IVD devices should complete the DOC as soon as possible
Manufacturers of IVD devices that do not require Notified Body participation for IVDD but require Notified Body participation for IVDR should complete the DOC as soon as possible (before May 26, 2022) in accordance with IVDD to qualify for the buffer periRead more -
Responses of IVDD Enterprises
For manufacturers of IVD devices that neither the IVDD nor the IVDR require the participation of a Notified Body, compliance procedures should be completed as soon as possible in accordance with IVDR 2017/746. Procedures include:1) Prepare technical documRead more -
IVDR extension content
1. The latest expiration date of IVD devices (List A, List B, self-testing devices) that have obtained the CE certificate of the notified body according to the IVDD Directive 98/79/EC is May 26, 2025.2. Devices that do not require the intervention of a noRead more -
Rapid Antigen Test For Covid-19 (EU) IVDD CE requirements and procedures
During the transition period of IVDR extension until May 26, 2025, manufacturers of new crown reagents can apply for EU registration, EU generation, CE technical documents, and DOC to complete CE compliance export to EU according to IVDD other category.OnRead more -
how to read the results of the coronavirus antigen kit ？
In general, the results of the coronavirus antigen kit are the same as those of the pregnancy test stick. After two bars, you need to go to the hospital for re examination, because there is still a probability of “false positive”~Four points should be paiRead more -
What is the detection principle of the new crown antigen reagent? Is the accuracy high?
From December 2019 to the end of March 2022, it has been two and four months since COVID-19 threatened.Due to the rapid spread of omicron, China is currently facing more difficult epidemic prevention tasks than those in early 2020.In Shanghai, 2022,03 addRead more -
What do you think of the start of the distribution of new crown self-test kits in China?
On March 11, the Comprehensive group of the Joint prevention and control mechanism for COVID-19 decided to add antigen testing on the basis of nucleic acid testing.On March 12 and 13, the State Food and Drug Administration issued a notice approving COVIDRead more -
What do you think of the start of the distribution of new crown self-test kits in China?
In view of the new characteristics of Omicron mutants, a faster and more convenient primary screening method is needed to carry out large-scale personnel screening. Although Home COVID Test Kit is not as high as that of nucleic acid detection, it is conveRead more