BioMérieux announced on Tuesday that its BioFire SpotFire Respiratory Panel Mini has obtained CLIA wavier from the US Food and Drug Administration.
Qiagen said Monday that its QIAstat-Dx syndromic testing system is expected to be available soon in Japan with a SARS-CoV-2 Respiratory Panel that can detect more than 20 pathogens from a patient sample.
Visby Medical's respiratory panel test has received Emergency Use Authorization from the US Food and Drug Administration, according to a letter from the agency.
Seegene said on Wednesday that it has received Australian approval and CE-IVD marking for its Allplex RV Master Assay for respiratory viruses.
Roche said on Wednesday that three of its molecular respiratory panels have received CE marking and have been launched in countries accepting the CE mark.
Mesa Biotech recently said that the US Food and Drug Administration has cleared and CLIA-waived the companys Accula RSV respiratory syncytial virus test for diagnostic use in both children and adults. According to the San Diego-based firm,
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