Tellgen Corporation (300642.SZ) announced that its application for medical device registration has recently been accepted by the National Medical Products Administration. The product in question is the "Human Immunodeficiency Virus Antigen-Antibody Combo Detection Kit (Chemiluminescence Immunoassay)."
This accepted product can detect HIV-1 P24 antigen, as well as antibodies for HIV-1, HIV-2, and HIV-1 Group O, enabling earlier detection of HIV infection status. It is intended for the auxiliary clinical diagnosis of HIV-1 and HIV-2 virus infections. The test results do not specifically differentiate between reactivity for HIV-1 P24 antigen, HIV-1 antibody, HIV-2 antibody, or HIV-1 Group O antibody.
This product, now accepted, was developed by the company based on its chemiluminescence technology platform for the infectious disease testing sector. Its acceptance is beneficial for enriching the company's product portfolio. A comprehensive and diverse product line helps the company meet market demands more fully and further enhances its market competitiveness.