FDA Device Entity Profile: ORASURE TECHNOLOGIES, INC.

Known Identifiers & Locations

FEI Numbers 3003297763, 3004142665, 3022474803

Owner Operator Numbers 9000083

Locations Covered BETHLEHEM, PA, US; Bethlehem, PA, US

Registered Establishments (3)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
3003297763	ORASURE TECHNOLOGIES, INC.	Bethlehem, PA, US	Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility	View Details
3004142665	ORASURE TECHNOLOGIES INC.	BETHLEHEM, PA, US	Manufacture Medical Device	View Details
3022474803	ORASURE TECHNOLOGIES, INC.	Bethlehem, PA, US	Repack or Relabel Medical Device	View Details

510(k) Premarket Notifications (0)

No 510(k) notifications found for this entity.

FDA Recall History (0)

No recall records found for this entity.

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