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FDA 510(k)

Xpert MRSA/SA SSTI

K-Number: K243625 · 2024-12-18

ApplicantCepheid®
Decision Date2024-12-18
Product CodeNQX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Xpert MRSA/SA SSTI is a medical device manufactured by Cepheid®. It received FDA 510(k) clearance on 2024-12-18 under approval number K243625. 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/SA SSTI?

Xpert MRSA/SA SSTI is a medical device that received FDA 510(k) clearance on 2024-12-18. It is manufactured by Cepheid®. The 510(k) number is K243625.

When was Xpert MRSA/SA SSTI approved by the FDA?

Xpert MRSA/SA SSTI received FDA 510(k) clearance on 2024-12-18, under approval number K243625.

What company makes Xpert MRSA/SA SSTI?

Xpert MRSA/SA SSTI is manufactured by Cepheid®.

What is the FDA product code for Xpert MRSA/SA SSTI?

The FDA product code for Xpert MRSA/SA SSTI is NQX.

Other Devices by Cepheid®

K230440Xpert® Xpress CoV-2 plus K231481Xpert Xpress CoV-2/Flu/RSV plus K223046Xpert® FII & FV K243405Xpert vanA K243070Xpert® SA Nasal Complete K250995Xpert Xpress CoV-2/Flu/RSV plus

View all 10 devices →

Related Devices (Code: NQX)

K162444Xpert MRSA NxGCepheid K191742ARIES MRSA AssayLuminex Corporation K190771Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 SystemCepheid K243070Xpert® SA Nasal CompleteCepheid®

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.

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