Xpert Hemorrhagic Fever
FDA 510(k) K253653 · Cepheid
510(k) numberK253653
Submission
- Device name
- Xpert Hemorrhagic Fever
- Applicant
- Cepheid
Sunnyvale, CA, US - Received
- November 20, 2025
- Decision date
- February 20, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
No product code recorded.
More from Cepheid
| 510(k) | Device | Decision |
|---|---|---|
| K261362 | Xpert Hemorrhagic FeverQVR · Dual Track | 08/07/2026SE |
| K261867 | Xpert Carba-RPOC · Special | 07/02/2026SE |
| K251721 | Xpert GI PanelPCH · Traditional | 01/16/2026SE |
| K250996 | Xpert Xpress CoV-2/Flu/RSV plusQOF · Special | 05/01/2025SE |
| K250995 | Xpert Xpress CoV-2/Flu/RSV plusQOF · Special | 05/01/2025SE |
| K243730 | Xpert C. difficile/EpiOZN · Traditional | 02/28/2025SE |
| K250218 | Xpert® FII & FVNPR · Special | 02/21/2025SE |
| K242109 | Xpert® Xpress CoV-2 plus (XPRS-COV2-10)QQX · Dual Track | 01/15/2025SE |
| K242071 | Xpert Xpress CoV-2/Flu/RSV plusQOF · Dual Track | 01/10/2025SE |
| K243625 | Xpert MRSA/SA SSTINQX · Special | 12/18/2024SE |
Questions and answers
When was Xpert Hemorrhagic Fever cleared by the FDA?
Xpert Hemorrhagic Fever (K253653) received a 510(k) decision of Substantially Equivalent on February 20, 2026, 92 days after the submission was received.