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HAYWARD, California - Biolog, Inc. announced Tuesday that its anaerobic media and chambers have received CE marking, allowing the company to expand into the European diagnostic market.
The certification enables European clinical laboratories to use Biolog’s TruPRAS™ media, which has been FDA-approved for In Vitro Diagnostic use in the United States. The media received CE marking under the EU IVDR regulation 2017/746.
According to the company’s press release statement, Biolog’s anaerobic media is manufactured under pre-reduced, anaerobically sterilized conditions to prevent the formation of byproducts that could harm anaerobic organisms.
"The IVDR/CE mark is a major milestone that recognizes the high standard of our anaerobic media and its value in supporting critical diagnostic workflows," said Robert Wicke, CEO at Biolog.
The company’s anaerobic chambers also received CE marking, confirming their safety and performance standards for research settings across Europe. The chambers feature InstaSleeve™ technology, which allows for gloveless operation.
Biolog is also releasing an upgrade that will enable the chambers to create hypoxic or microaerophilic conditions for organisms requiring specific low oxygen concentrations.
The products were acquired when Biolog purchased Anaerobe Systems earlier this year. The company states the anaerobic media has had no recalls or field actions throughout its history.
Biolog provides tools for microbial identification and characterization for clinical, microbiome, and agricultural markets.
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