Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress System (GX-I)— 510(k) K151226

Substantially Equivalent

Cepheid

FDA 510(k) clearance K151226 for Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress System (GX-I), Substantially Equivalent on 2015-12-03. Applicant: Cepheid.

Clearance details

Applicant: Cepheid
Product code: Code OCC
Advisory panel: Microbiology
Date received: 2015-05-07
Decision date: 2015-12-03
Decision: Substantially Equivalent
Clearance type: Dual Track
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OCC

product code OCC

Death: 3
Malfunction: 706
Total: 709

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.