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FDA 510(k)

Xpert® SA Nasal Complete

K-Number: K243070 · 2024-10-25

ApplicantCepheid®
Decision Date2024-10-25
Product CodeNQX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Xpert® SA Nasal Complete is the device name listed in this FDA 510(k) record. The listed applicant is Cepheid®. It received FDA 510(k) clearance on 2024-10-25 under 510(k) number K243070. 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® SA Nasal Complete?

Xpert® SA Nasal Complete is a medical device that received FDA 510(k) clearance on 2024-10-25. The listed applicant is Cepheid®. The 510(k) number is K243070.

When did Xpert® SA Nasal Complete receive FDA 510(k) clearance?

Xpert® SA Nasal Complete received FDA 510(k) clearance on 2024-10-25, under 510(k) number K243070.

Who is the listed applicant for Xpert® SA Nasal Complete?

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® SA Nasal Complete?

The FDA product code for Xpert® SA Nasal Complete 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 FeverK261867Xpert Carba-RK253653Xpert Hemorrhagic FeverK251721Xpert GI PanelK250996Xpert Xpress CoV-2/Flu/RSV plusK250995Xpert Xpress CoV-2/Flu/RSV plus

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Related Devices (Code: NQX)

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.

K243625Xpert MRSA/SA SSTICepheid®K191742ARIES MRSA AssayLuminex CorporationK190771Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 SystemCepheidK162444Xpert 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.

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