FDA Device Establishments · JSON-LD · Markdown

ROCHE DIAGNOSTICS INTERNATIONAL LTD.

FEI 3003795116 · Manufacture Medical Device · Status: Active

FEI Number3003795116
Owner / OperatorRoche Diagnostics Operations Inc. (#9039767)
AddressFORRENSTRASSE 2, ROTKREUZ Zug, CH-6343, CH
Mandatory US AgentRoche Diagnostics Operations Inc
Registration expiry2026
Initial importer flagN
Registered products3
Product codes (top 20)LSL, MKZ, QEP
Regulation § (21 CFR)866.3390, 866.3120, 866.3393
Proprietary namesSW 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

External sources

Source: openFDA. Public-domain (CC0).