FDA Class I Listing Completed for Celemics NGS Products (Read the full article: https://Inka.in/gj-3gJYf)
Celemics' major NGS products have completed FDA Class
1 Device Listing and are officially included in the FDA
Registration and Listing database.
As regulatory expectations continue to evolve in the U.S., clinical laboratories and LDT developers increasingly require reagents and panels that support quality systems, traceability, and documentation. FDA Class I listing provides an important regulatory foundation to support these needs.
This milestone reinforces Celemics' commitment to transparency, quality-driven manufacturing, and long-term support for regulated laboratory environments, including CLIA-certified and LDT workflows.
Celemics will continue to expand its NGS portfolio and capabilities to support reliable, traceable, and regulation-aligned genomics workflows for clinical and translational research.
#ngs #clinicalgenomics #Idt #fda #moleculardiagnostics #genomicresearch
