DeviceClearance

K183597

Substantially Equivalent

QIAstat-Dx Respiratory Panel

Applicant
QIAGEN GmbH
Product code
OCC
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Hilden, DE
Download summary PDF View on FDA.gov ↗

Adverse events under product code OCC

product code OCC
Death
3
Malfunction
706
Total
709

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.