DeviceClearance

K161495

Substantially Equivalent

ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD)

Applicant
Luminex Corporation
Product code
OOI
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Austin, TX, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code OOI

product code OOI
Malfunction
2,506
Other
3
Total
2,509

Source: openFDA MAUDE database, through . 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.