Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Xpert Xpress Strep A

K-Number: K172126 · 2017-09-25

ApplicantCepheid
Decision Date2017-09-25
Product CodePGX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Xpert Xpress Strep A is a medical device manufactured by Cepheid. It received FDA 510(k) clearance on 2017-09-25 under approval number K172126. The device is classified under product code PGX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Xpert Xpress Strep A?

Xpert Xpress Strep A is a medical device that received FDA 510(k) clearance on 2017-09-25. It is manufactured by Cepheid. The 510(k) number is K172126.

When was Xpert Xpress Strep A approved by the FDA?

Xpert Xpress Strep A received FDA 510(k) clearance on 2017-09-25, under approval number K172126.

What company makes Xpert Xpress Strep A?

Xpert Xpress Strep A is manufactured by Cepheid.

What is the FDA product code for Xpert Xpress Strep A?

The FDA product code for Xpert Xpress Strep A is PGX.

Other Devices by Cepheid

K162444Xpert MRSA NxG K161619Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48, Genxpert Infinity-48s and GeneXpert Infinity-80 Systems K160901Xpert Carba-R K152614Xpert Carba-R K171552Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV K162456Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48 System and GeneXpert Infinity-48s System, GeneXpert Infinity-80 System

View all 26 devices →

Related Devices (Code: PGX)

K162274Solana Strep Complete AssayQuidel Corporation K172402ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File KitLuminex Corporation K173653Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab KitAlere Scarborough, Inc. K173398Xpert Xpress Strep ACepheid K183366GenePOC Strep AGenepoc, Inc. K201269Accula Strep A TestMesa Biotech, 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.

↑