BD GENEOHM MRSA ACP ASSAY— 510(k) K093346
Substantially EquivalentBd Diagnostics (Geneohm Sciences, Inc.)
FDA 510(k) clearance K093346 for BD GENEOHM MRSA ACP ASSAY, Substantially Equivalent on 2009-12-15. Applicant: Bd Diagnostics (Geneohm Sciences, Inc.). Device class: 2.
Clearance details
- Applicant
- Bd Diagnostics (Geneohm Sciences, Inc.)
- Product code
- Code NQX
- Device class
- Class 2
- Regulation
- 21 CFR 866.1640
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Recent devices under product code NQX
view allMore clearances from Bd Diagnostics (Geneohm Sciences, Inc.)
view allRecalls naming K093346
K-number listed on FDA's recall record- Z-2316-2012 — BD GeneOhm MRSA ACP Assay Catalog #441637, box 48 tests labeled in part***GeneOhm Sciences Canada, Inc., 2555 boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5*** BD GeneOhm MRSA ACP Assay is a qualitative in vitro diagnostic test for the direct detection of methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patients at risk for nasal colonization. Test is intended to aid in the prevention and control of MRSA infections in healthcare settings. It is not intended to diagnose MRSA infections nor to guide or monitor treatment for MRSA infections.
- Z-2317-2012 — BD GeneOhm MRSA ACP Assay, Catalog #441639, box 200 tests labeled in part***GeneOhm Sciences Canada, Inc. 2555 Boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5*** BD GeneOhm MRSA ACP Assay is a qualitative in vitro diagnostic test for the direct detection of methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patients at risk for nasal colonization. Test is intended to aid in the prevention and control of MRSA infections in healthcare settings. It is not intended to diagnose MRSA infections nor to guide or monitor treatment for MRSA infections. .
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K093346.
Data sourced from openFDA. This site is unofficial and independent of the FDA.