K120959

Substantially Equivalent

BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT

Applicant: Bio-Rad Laboratories
Product code: MXJ
Advisory panel: Microbiology
Date received: 2012-03-30
Decision date: 2012-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Benicia, CA, US

Adverse events under product code MXJ

product code MXJ

Injury: 139
Total: 139

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.