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Diagnostics Regulatory News & FDA Approvals

The latest regulatory news and FDA approvals.

Bio-Rad's PCR-based test is designed to detect SARS-CoV-2 nucleic acid, while United Biomedical's test detects antibodies against the virus.

The kit was jointly developed by Singapore's Agency for Science, Technology, and Research, Tan Tock Seng Hospital, and MiRxes.

The test has been authorized for use with individual respiratory specimens, as well as with pooled specimens containing up to five samples.

The company continues to face regulatory challenges in the US, but received CE marking for its DPP SARS-CoV-2 Antigen and IgM/IgG test systems.

The fluoro-enzyme immunoassay is designed for the qualitative and semi-quantitative detection of immunoglobulin G against SARS-CoV-2.