# ROCHE MOLECULAR SYSTEMS, INC.

FEI: 3004141078
Status: Active
Establishment types: Develop Specifications But Do Not Manufacture At This Facility
Owner/operator: Roche Diagnostics Operations Inc. (#9039767)

Address: 4300 HACIENDA DRIVE, PLEASANTON, CA, US



## Products

Total registered: 1
Top product codes: OWD
Regulation §: —

Proprietary names: cobas® EZH2 Mutation Test, cobas® EZH2 Analysis Package Software version 1, KIT COBAS 4800 EZH2 AMP/DET 24T IVD, SW C4800 EZH2 AP V1 CD

## Source

- openFDA: https://api.fda.gov/device/registrationlisting.json?search=registration.fei_number:%223004141078%22
- FDA Registration Lookup: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=3004141078