Abstract
Recently, Nanjing Liming Bio-Products Co., Ltd. (www.limingbio.com)SARS-COV-2 lgM/IgG Antibody Rapid Test Kit has been certified by the Brazilian National Health Supervision Bureau and obtained the ANVISA certification. At the same time, the SARS-CoV-2 RT-PCR and the IgM/IgG antibody rapid test kit are also listed on the official recommended procurement list of Indonesia.
Picture 1 the Brazil ANVISA certification
Brazil (ANVISA) certification
ANVISA, known as Agência Nacional de Vigilância Sanitária, is the Brazilian medical device regulator. It is necessary for a company to be registered with ANVISA, the National Health Supervision Agency, to sell medical devices legally in Brazil. To be certified, those medical devices entering Brazil must meet the requirements of Brazilian GMP along with the specific standards set by the Brazilian authorities. In Brazil, IVD medical devices are classified into Class I, II, III, and IV according to the risk level from low to high. For Class I and II products, the Cadastro approach is adopted, while for Class III and IV products, the Registro approach is utilized. After successful registration, a registration number will be issued by ANVISA, and the data will be uploaded to the Brazilian medical device database, this number and its corresponding registration information will appear on DOU (Diário Oficial da União).
Picture 2 The official recommended procurement list of Indonesia
Picture 3 StrongStep® SARS-CoV-2 IgM/IgG Antibody Rapid Test
Picture 4 Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR kit
Note:
This highly sensitive, ready-to-use PCR kit is available in lyophilized format (freeze-drying process) for long-term storage. The kit can be transported and stored at room temperature and is stable for one year. Each tube of premix contains all of the reagents needed for the PCR amplification, including Reverse-transcriptase, Taq polymerase, primers, probes, and dNTPs substrates. It only need add 13ul distilled water and 5ul extracted RNA template , then it can be run and amplified on the PCR instruments.
SARS-CoV-2 IgM/IgG Antibody Rapid Test and Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit (detection for three genes) has previously been CE marked in the UK, and now accepted and being processed by EUA of FDA in America.
The second COVID-19 outbreak in Europe has spread recently. Facing the COVID-19, the situation is becoming increasingly serious. Nanjing Liming Bio-Products Co., Ltd. has assumed its due and social responsibility. Combining the company's advantages in the development of microbial diagnostic reagents, the SARS-CoV-2 IgM/IgG Antibody Rapid Test and Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit (detection for three genes) (freeze-dried powder) developed by the company have been highly praised by the market.
Meanwhile, the SARS-CoV-2 Antigen Rapid Test (Latex immunochromatography) has been newly improved and developed, which will be released shortly after.
Nanjing Liming Bio-Products Co., Ltd. has always put the quality of the test kit in the first place, and is concentrating on the expansion of the capacity. The company will provide high-quality COVID-19 testing products and services to medical institutions all around the world, and contribute to the global epidemic prevention and control, so as to build a global community of shared future.
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Email: sales@limingbio.com
Website: https://limingbio.com
Post time: Jul-19-2020
