Chembio Diagnostics
In Brief This Week: BioMérieux, LumiraDx, Chembio Diagnostics, Quanterix, Quest Diagnostics, More
News items for the in vitro diagnostics industry for the week of May 16, 2022.
Chembio Q1 Revenues More Than Double
Despite the revenue gains, the company said that there is substantial doubt about its ability to continue operations into 2023.
A few firms have made de novo or 510(k) submissions, but many are waiting as they continue to assess the market for their tests and look to the FDA for further guidance.
Chembio Diagnostics Q4 Revenues More Than Double Over Last Year
Despite the revenue gains, the company said that a number of issues have raised substantial doubt about its ability to continue operations.
Chembio Diagnostics Submits FDA De Novo/510(k) Request for SARS-CoV-2 Antigen Test System
An award from BARDA provided funding to support the completion of clinical studies and preparation of a regulatory submission for the DPP SARS-CoV-2 Antigen test system.