Tellgen Corporation (300642.SZ): Human Immunodeficiency Virus Antigen Antibody Combo Test Kit (Chemiluminescent Immunoassay) Medical Device Registration Accepted.
Translucent Life (300642.SZ) announced that the medical device registration application submitted by the company has recently been accepted by the National Medical Products Administration. The product is a "HIV antigen-antibody combination test kit (chemiluminescent immunoassay)".
Tellgen Corporation (300642.SZ) announced that the medical device registration application submitted by the company has recently been accepted by the National Medical Products Administration. The product is: "HIV antigen-antibody combination test kit (chemiluminescent immunoassay)".
The accepted product mentioned above can detect HIV-1 P24 antigen, as well as HIV-1 type, HIV-2 type, and HIV-1 type O group antibodies, enabling earlier detection of HIV virus infection status for clinical auxiliary diagnosis of HIV-1 virus and HIV-2 virus infection. The test results do not specifically differentiate between HIV-1 P24 antigen, HIV-1 antibody, HIV-2 antibody, or HIV-1 type O group antibody reactivity.
The product accepted this time is a product developed by the company based on the chemiluminescent technology platform in the field of infection detection, which will enrich the company's product portfolio. A rich and complete product line helps the company meet market demand comprehensively and further enhances the company's market competitiveness.
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