510(k) K042357 ยท NQX System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
IDI-MRSA ASSAY
| Applicant | Infectio Diagnostic (I.D.I.), Inc., Hydes MD, US |
| Decision | Substantially Equivalent, Oct 22, 2004 |
| Received | Aug 31, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K042357
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 10, 2009 | BD Diagnostics (GeneOhm Sciences, Inc) BD Diagnostics, BD GeneOhm MRSA Assay, REF: 441242 (200 Reaction Kit) and 441244 (48 Reaction Kit).
For the rapid detection of methicillin resistant MRSA DNA in nasal specimen. Terminated |
NQX | None listed |
| Oct 31, 2008 | BD Diagnostics (GeneOhm Sciences, Inc) BD GeneOhm MRSA 200 ct, Catalog #441242. IDI-MRSA assay is a qualitative in vitro diagnostic test for the direct detection of nasal colonization by methicillin-resistant Staphylococcus aureus (MRSA) Terminated |
NQX | None listed |
| Oct 31, 2008 | BD Diagnostics (GeneOhm Sciences, Inc) BD GeneOhm MRSA 48 ct, Catalog #441244. IDI-MRSA assay is a qualitative in vitro diagnostic test for the direct detection of nasal colonization by methicillin-resistant Staphylococcus aureus (MRSA) t Terminated |
NQX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.