510(k) K181289— Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48S System and GeneXpert Infinity-80 System

Substantially Equivalent

Cepheid

Clearance details

Applicant: Cepheid
Product code: Code OCC
Advisory panel: Microbiology
Date received: 2018-05-16
Decision date: 2018-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

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.