Biolog, a leading provider of microbial identification and phenotypic characterization tools and services, announced today that both its anaerobic media and anaerobic chambers have received CE marking, clearing the way for broader international use
Biolog, a leading provider of microbial identification and phenotypic characterization tools and services, announced today that both its anaerobic media and anaerobic chambers have received CE marking, clearing the way for broader international use. The media and chambers were part of Biolog’s acquisition of Anaerobe Systems earlier this year with the objective of bringing class-leading tools for microbiology to the rapidly growing clinical, microbiome, and agricultural markets.
Today, Biolog’s TruPRAS™ media is the only commercial media manufactured under true pre-reduced, anaerobically sterilized conditions, preventing the formation of harmful byproducts that can be toxic to anaerobic organisms. This line of media products, which has been approved for In Vitro Diagnostic (IVD) use by the USA FDA for years, has now also achieved CE marking under the requirements of the EU IVDR regulation 2017/746. With zero recalls or field actions throughout their extensive history, these products enable transport of specimens and growth of fastidious anaerobes that play important roles in disease pathology – supporting clinical diagnostics in medical laboratories.
“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. “We’re proud that clinical labs throughout Europe can now benefit from the same reliable performance that researchers and clinicians in the U.S. have trusted for decades.”
Biolog’s anaerobic chambers have also received the CE mark, affirming their safety and performance for use in any research settings throughout the world. With unique InstaSleeve™ technology, these ergonomic, gloveless chambers offer superior processing dexterity while working in a fully anaerobic environment and are a preferred tool for microbiologists in both clinical and academic settings. In addition, Biolog is releasing an upgrade to enable hypoxic or microaerophilic conditions in the same chamber, for organisms that require specific, low concentrations of oxygen to thrive.
“This dual achievement reinforces Biolog’s commitment to advancing global access to high-quality tools for anaerobic microbiology,” said Wicke. “Whether you’re working with challenging clinical isolates or conducting fundamental research, Biolog now provides dependable CE-marked solutions that meet your needs.”
About Biolog
Biolog offers tools, services, and support for comprehensive cellular characterization and multi-omic identification of bacteria, yeast, and fungi. Our products also enable phenotypic profiling of microbial and mammalian cells for a range of applications, including supporting the culture of fastidious anaerobes with our line of gloveless chambers and pre-reduced media. Learn more at biolog.com
Contact Information
John Proctor, Ph.D.
CCO
jproctor@biolog.com
(408)306-0414
SOURCE: Biolog, Inc.