Source document or public record
FDA 510(k) K213804 — cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems
FDA 510(k) index record K213804. Device: cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems. Applicant as listed: Roche Molecular Systems, Inc.. Decision date: 2022-10-22.
Source
"device_name": "cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
Review and references
Automated FDA record verification
2026-10-20
2026-10-20
professional use
FDA 510(k) public index record K213804.
Device name: cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems. Applicant as listed: Roche Molecular Systems, Inc..
Decision date: 2022-10-22. Decision wording: Substantially Equivalent.
Product code: QQX. Regulation: 21 CFR 866.3981. Medical specialty: Microbiology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
Interested in these solutions?
Submit a sourcing request with the assays, volumes, and timeline of your own project.