510(k) K070462 ยท NQX System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
XPERT MRSA
| Applicant | Cepheid, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Apr 17, 2007 |
| Received | Feb 16, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070462
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 18, 2016 | Cepheid Xpert MRSA
Catalog GXMRSA-120, Rev. AJ
Microbiology:
The Cepheid Xpert MRSA assay performed in the GeneXpert Dx System
(Xpert MRSA) is a qualitative in vitro diagnostic test designed for rapid detec Terminated |
NQX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.