K812808

Substantially Equivalent

BBL DIRECTIGEN TEST KIT

Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code: GTY
Advisory panel: Microbiology
Date received: 1981-10-06
Decision date: 1981-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Adverse events under product code GTY

product code GTY

Death: 2
Total: 2

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.