Applied BioCode Announces FDA Clearance for KingFisher™ Nucleic Acid Extraction with BioCode® Respiratory Pathogen Panel for IVD Use
This enhancement to the BioCode® RPP enables seamless integration of the KingFisher™ Flex extraction platform and the BioCode® MDx-3000 automated detection system, expanding the panel’s utility and increasing throughput for respiratory testing. Clinical laboratories using these extraction systems can now streamline their workflows by pairing them with the BioCode® RPP, providing an affordable and comprehensive solution for detecting 17 prevalent respiratory pathogens. By improving workflow efficiency, this new claim is expected to enhance patient care by accelerating the delivery of accurate and timely diagnostic results.
“Adding the Thermo Fisher KingFisher™ Flex extraction system demonstrates Applied BioCode’s commitment to delivering flexible, high-quality solutions for the molecular diagnostics market,” said Dr.
This submission builds on Applied BioCode’s previous FDA clearance of the BioCode®
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For more information about the new nucleic acid extraction claim for BioCode® RPP or to learn more about Applied BioCode’s innovative diagnostic solutions, please visit https://www.apbiocode.com/products/.
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