510(k) K120138 ยท NQX System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
BD MAX MRSA ASSAY, BD MAX INSTRUMENT
| Applicant | Bd Diagnostics (Geneohm Sciences Canada, Inc), Sparks MD, US |
| Decision | Substantially Equivalent, Jul 5, 2012 |
| Received | Jan 17, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120138
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 23, 2025 | Becton Dickinson & Co. BD MAX System, for in vitro diagnostic (IVD) use, labeled as the following:
1. BD MAX System, BD MAX Instrument, Catalog Numbers: 44191609, 441927. Open, Classified |
OZN | None listed |
| Dec 3, 2024 | Becton Dickinson & Co. BD MAX System, BD MAX Instrument
Version or Model: 441916
Catalog Number: 441916 Open, Classified |
OZN | None listed |
| Jul 17, 2019 | Becton Dickinson & Co. Kit BD Max MRSA;
Catalog # 442953 Terminated |
NQX | None listed |
| Sep 10, 2014 | Becton Dickinson & Co. The BD MAX MRSA Assay, catalogue #442953.
An automated qualitative in vitro diagnostic test for the direct detection of Methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in pati Terminated |
NQX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.