Xpert® Xpress CoV-2 plus— 510(k) K230440
Substantially EquivalentCepheid®
FDA 510(k) clearance K230440 for Xpert® Xpress CoV-2 plus, Substantially Equivalent on 2023-10-13. Applicant: Cepheid®. Device class: 2.
Clearance details
- Applicant
- Cepheid®
- Product code
- Code QQX
- Device class
- Class 2
- Regulation
- 21 CFR 866.3981
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
Recent devices under product code QQX
view all- K243396 — Aptima SARS-CoV-2 Assay
- K240867 — cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems
- K242109 — Xpert® Xpress CoV-2 plus (XPRS-COV2-10)
- K241580 — Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086)
- K233453 — Applied Biosystems TaqPath COVID-19 Diagnostic PCR Kit
More clearances from Cepheid®
view allData sourced from openFDA. This site is unofficial and independent of the FDA.