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Diagnostics Regulatory News & FDA Approvals

The latest regulatory news and FDA approvals.

The agency confused and upset many in the healthcare community last month when it said asymptomatic patients did not need to be tested.

The test targets antibodies for the viral spike protein and can characterize a vaccine-induced immune response.

Visby's test is a fully integrated PCR device that detects SARS-CoV-2 RNA, while SNIBE's test comprises assays for two different antibodies against the virus.

The test, which received EUA from the US Food and Drug Administration in April, is designed to detect human IgG antibodies in serum and plasma.

The proposed order is intended to give patients more timely access to the tests by moving them from Class III to Class II and providing special controls.