FDA Device Entity Profile: Gold Standard Diagnostics

Known Identifiers & Locations

FEI Numbers 3007208259, 3008191245

Owner Operator Numbers 10025460, 10031124

Locations Covered Davis, CA, US; Dietzenbach Hesse, DE

Registered Establishments (2)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
3007208259	GOLD STANDARD DIAGNOSTICS, LLC	Davis, CA, US	Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility	View Details
3008191245	Gold Standard Diagnostics Frankfurt GmbH	Dietzenbach Hesse, DE	Manufacture Medical Device for Another Party (Contract Manufacturer)	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.

Profile Disclaimer

AvaSpecs compiles public data records from the FDA database. This compiled profile does not indicate endorsement, safety, clearance, approval, or compliance status. AvaSpecs is a private search index and is not affiliated with the FDA or any government agency.