Xpert MRSA NxG
K-Number: K162444 · 2016-11-23
ApplicantCepheid
Decision Date2016-11-23
Product CodeNQX
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
Xpert MRSA NxG is a medical device manufactured by Cepheid. It received FDA 510(k) clearance on 2016-11-23 under approval number K162444. The device is classified under product code NQX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Xpert MRSA NxG?
Xpert MRSA NxG is a medical device that received FDA 510(k) clearance on 2016-11-23. It is manufactured by Cepheid. The 510(k) number is K162444.
When was Xpert MRSA NxG approved by the FDA?
Xpert MRSA NxG received FDA 510(k) clearance on 2016-11-23, under approval number K162444.
What company makes Xpert MRSA NxG?
Xpert MRSA NxG is manufactured by Cepheid.
What is the FDA product code for Xpert MRSA NxG?
The FDA product code for Xpert MRSA NxG is NQX.
Other Devices by Cepheid
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
K162456Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48 System and GeneXpert Infinity-48s System, GeneXpert Infinity-80 System
Related Devices (Code: NQX)
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.