510(k) K243070 · NQX System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
Xpert® SA Nasal Complete
| Applicant | Cepheid®, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Oct 25, 2024 |
| Received | Sep 27, 2024 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K243070
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 30, 2025 | Cepheid Xpert SA Nasal Complete
Catalog Number: GXSACOMP-10
UDI-DI code: 07332940000158
Xpert SA Nasal Complete kit; 10 test kit: A collection of reagents and other associated materials intended to be used f Open, Classified |
NQX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.