OraSure Technologies, Inc. - Aug. 25, 2015
Issue Date
Aug 25, 2015
Region
Central
Category
Device
$117.00
Contact Name
Douglas A. Michels
Contact Title
President and CEO
Address 1
150 Webster St.
City
Bethlehem
State
PA
Zip/Postal Code
18015
Country
United States
Inspection Range
Aug 19, 2015 - Aug 25, 2015
Pages
2
First Observation
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury.
Investigator(s): Brian S. Keefer