FDA 510(k)

Xpert MRSA/SA SSTI

K-Number: K243625 · 2024-12-18

Decision Date2024-12-18

Product CodeNQX

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

Xpert MRSA/SA SSTI is the device name listed in this FDA 510(k) record. The listed applicant is Cepheid®. It received FDA 510(k) clearance on 2024-12-18 under 510(k) 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. The listed applicant is Cepheid®. The 510(k) number is K243625.

When did Xpert MRSA/SA SSTI receive FDA 510(k) clearance?

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

Who is the listed applicant for Xpert MRSA/SA SSTI?

The FDA 510(k) record lists Cepheid® as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Cepheid® as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261362Xpert Hemorrhagic Fever K261867Xpert Carba-R K253653Xpert Hemorrhagic Fever K251721Xpert GI Panel K250996Xpert Xpress CoV-2/Flu/RSV plus K250995Xpert Xpress CoV-2/Flu/RSV plus

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Related Devices (Code: NQX)

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

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.