Xpert Xpress Strep A
K-Number: K173398 · 2018-04-26
ApplicantCepheid
Decision Date2018-04-26
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 2018-04-26 under approval number K173398. 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 2018-04-26. It is manufactured by Cepheid. The 510(k) number is K173398.
When was Xpert Xpress Strep A approved by the FDA?
Xpert Xpress Strep A received FDA 510(k) clearance on 2018-04-26, under approval number K173398.
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
K172126Xpert Xpress Strep A
Related Devices (Code: PGX)
K162274Solana Strep Complete AssayQuidel Corporation
K172402ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File KitLuminex Corporation
K172126Xpert Xpress Strep ACepheid
K173653Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab KitAlere Scarborough, Inc.
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.