Xpert® FII & FV
K-Number: K250218 · 2025-02-21
ApplicantCepheid
Decision Date2025-02-21
Product CodeNPR
Advisory CommitteeHE
DecisionSubstantially Equivalent
Device Summary
Xpert® FII & FV is a medical device manufactured by Cepheid. It received FDA 510(k) clearance on 2025-02-21 under approval number K250218. The device is classified under product code NPR. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Xpert® FII & FV?
Xpert® FII & FV is a medical device that received FDA 510(k) clearance on 2025-02-21. It is manufactured by Cepheid. The 510(k) number is K250218.
When was Xpert® FII & FV approved by the FDA?
Xpert® FII & FV received FDA 510(k) clearance on 2025-02-21, under approval number K250218.
What company makes Xpert® FII & FV?
Xpert® FII & FV is manufactured by Cepheid.
What is the FDA product code for Xpert® FII & FV?
The FDA product code for Xpert® FII & FV is NPR.
Other Devices by Cepheid
K162444Xpert MRSA NxG
K161619Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48, Genxpert Infinity-48s and GeneXpert Infinity-80 Systems
K160901Xpert Carba-R
K152614Xpert Carba-R
K171552Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV
K172126Xpert Xpress Strep A
Related Devices (Code: NPR)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.