FDA Class I Listing Completed for Celemics NGS Products
Supporting Clinical Research and LDT Environments
As regulatory expectations continue to evolve in the United States, clinical laboratories are increasingly expected to demonstrate rigorous quality controls, validated workflows, and traceability of materials. For labs operating under CLIA certification or developing Laboratory Developed Tests (LDTs), the regulatory status of reagents and panels is no longer a secondary consideration—it is a core component of assay reliability and patient-driven decision-making. Celemics’ Five major NGS products have completed FDA Class I Device Listing and are included in the FDA registration and listing database, with Establishment Registration currently in progress. This achievement supports our commitment to transparency and compliance within the U.S. regulatory framework and reinforces the foundation for supplying products suitable for regulated laboratory environments.
Why This Matters in Clinical Research and LDT Workflows
For laboratories working in translational medicine, oncology, infectious disease, hereditary disease testing, or early-stage diagnostics, using FDA-listed Class I products may help support workflow standardization and quality management through the following:
- Improved workflow consistency and traceability
- Support for internal validation, verification, and documentation requirements
- Better preparation for evolving FDA oversight of LDTs
- Enhanced transparency regarding product origin and regulatory status
As oversight for LDTs continues to evolve, labs benefit from selecting reagents and panels that align with quality and compliance expectations.
Role of Establishment Registration
Beyond product listing, Establishment Registration ensures transparency and traceability regarding where the product is manufactured and under which quality system it is controlled. While FDA listing does not indicate product approval or clearance, it supports traceability and documentation expectations for clinical workflow development.
Value for Clinical and Translational Users
Clinical research laboratories can expect advantages in:
- Quality assurance and workflow control
- Assay validation and verification
- Long-term supply consistency
- Transparent documentation for audits and compliance
FDA Class I listing is an important regulatory step and contributes to confidence in traceability and supply oversight. It also complements validation efforts conducted by the clinical laboratory
Celemics will continue to expand capabilities and product offerings for laboratories that require both technical performance and regulatory-supported materials. FDA Class I listing represents one part of our broader effort to supply reliable and traceable NGS solutions for clinical genomics applications.
Celemics’ Five major NGS products have completed FDA Class I Listing, supporting regulated laboratory environments, including CLIA-certified and LDT workflows.
The following products are officially included in the FDA Registration and Listing database:
- FDA Class I Listed Products
– NGS Target Enrichment Panel (See Detail >)
– NGS (EP/LP) Library Preparation Kit (See Detail >)
– CLM Polymerase (See Detail >)
– Whole Exome Sequencing Panel (See Detail >)
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