FDA Device Establishments · JSON-LD · Markdown

ROCHE DIABETES CARE, INC.

FEI 3011393376 · Manufacture Medical Device · Status: Active

FEI Number3011393376
Owner / OperatorRoche Diagnostics Operations Inc. (#9039767)
Address9115 Hague Road, Indianapolis, IN, US
Registration expiry2026
Initial importer flagY
Registered products3
Product codes (top 20)NBW, LFR, JJX
Regulation § (21 CFR)862.1345, 862.1660
Proprietary namesACCU-CHEK Inform II Meter; ACCU-CHEK Inform II Control Solutions; ACCU-CHEK Inform II Linearity Test Kit; ACCU-CHEK Inform II Blood Glucose Monitoring System; ACCU-CHEK Inform II Meter Kit + RF; ACCU-CHEK Inform II Test Strip; ACCU-CHECK INFORM II US 50CT 72/CS F2; ACCU-HEK LINEARITY KIT U.S.; ACCU-CHEK INFORM II CNTRL US 6/CS; A/C Inform II Base Unit Kit

External sources

Source: openFDA. Public-domain (CC0).