K033106

Substantially Equivalent

CAPTIA HSV 2 IGG TYPE SPECIFIC ELISA KIT

Applicant: Trinity Biotech USA
Product code: MYF
Advisory panel: Microbiology
Date received: 2003-09-30
Decision date: 2004-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jamestown, NY, US

Adverse events under product code MYF

product code MYF

Injury: 316
Other: 1
Total: 317

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.