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FDA 510(k)

XPERT MRSA/SA SSTI ASSAY

K-Number: K080837 · 2008-09-24

ApplicantCepheid
Decision Date2008-09-24
Product CodeNQX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

XPERT MRSA/SA SSTI ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Cepheid. It received FDA 510(k) clearance on 2008-09-24 under 510(k) number K080837. 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 ASSAY?

XPERT MRSA/SA SSTI ASSAY is a medical device that received FDA 510(k) clearance on 2008-09-24. The listed applicant is Cepheid. The 510(k) number is K080837.

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

XPERT MRSA/SA SSTI ASSAY received FDA 510(k) clearance on 2008-09-24, under 510(k) number K080837.

Who is the listed applicant for XPERT MRSA/SA SSTI ASSAY?

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 ASSAY?

The FDA product code for XPERT MRSA/SA SSTI ASSAY 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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