# ROCHE DIAGNOSTICS INTERNATIONAL LTD.

FEI: 3003795116
Status: Active
Establishment types: Manufacture Medical Device
Owner/operator: Roche Diagnostics Operations Inc. (#9039767)

Address: FORRENSTRASSE 2, ROTKREUZ Zug, CH-6343, CH

Mandatory US Agent: Roche Diagnostics Operations Inc

## Products

Total registered: 3
Top product codes: LSL, MKZ, QEP
Regulation §: 866.3390, 866.3120, 866.3393

Proprietary names: SW USB COBAS LIAT CT/NG/MG V1.8, KIT COBAS LIAT CT/NG/MG IVD, cobas® liat CT, NG and MG control kit, cobas® liat CT/NG nucleic acid test, KIT COBAS LIAT CT/NG/MG CTL IVD, SW USB COBAS LIAT CT/NG V1.1, KIT COBAS LIAT CT/NG IVD, cobas® liat CT/NG/MG nucleic acid test

## Source

- openFDA: https://api.fda.gov/device/registrationlisting.json?search=registration.fei_number:%223003795116%22
- FDA Registration Lookup: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=3003795116