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FDA 510(k)

Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System

K-Number: K190771 · 2019-04-25

ApplicantCepheid
Decision Date2019-04-25
Product CodeNQX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System is the device name listed in this FDA 510(k) record. The listed applicant is Cepheid. It received FDA 510(k) clearance on 2019-04-25 under 510(k) number K190771. 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 Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System?

Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System is a medical device that received FDA 510(k) clearance on 2019-04-25. The listed applicant is Cepheid. The 510(k) number is K190771.

When did Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System receive FDA 510(k) clearance?

Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System received FDA 510(k) clearance on 2019-04-25, under 510(k) number K190771.

Who is the listed applicant for Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System?

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 Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System?

The FDA product code for Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System 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®K243070Xpert® SA Nasal CompleteCepheid®K191742ARIES MRSA AssayLuminex CorporationK162444Xpert 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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