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FDA 510(k)

XPERT MRSA

K-Number: K070462 · 2007-04-17

ApplicantCepheid
Decision Date2007-04-17
Product CodeNQX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

XPERT MRSA is the device name listed in this FDA 510(k) record. The listed applicant is Cepheid. It received FDA 510(k) clearance on 2007-04-17 under 510(k) number K070462. 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?

XPERT MRSA is a medical device that received FDA 510(k) clearance on 2007-04-17. The listed applicant is Cepheid. The 510(k) number is K070462.

When did XPERT MRSA receive FDA 510(k) clearance?

XPERT MRSA received FDA 510(k) clearance on 2007-04-17, under 510(k) number K070462.

Who is the listed applicant for XPERT MRSA?

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?

The FDA product code for XPERT MRSA is NQX.

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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.

K261336Xpert Respiratory PanelK261362Xpert Hemorrhagic FeverK261867Xpert Carba-RK253653Xpert Hemorrhagic FeverK251721Xpert GI PanelK250996Xpert 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®K243070Xpert® SA Nasal CompleteCepheid®K191742ARIES MRSA AssayLuminex CorporationK190771Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 SystemCepheidK162444Xpert MRSA NxGCepheidK133605BD MAX MRSA XT, BD MAX INSTRUMENTGeneohm Sciences Canada, Inc.

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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