Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011393376

FEI Number

3011393376

Entity Name

ROCHE DIABETES CARE, INC.

City/State/Country

Indianapolis, IN, US

Establishment Address

9115 Hague Road, Indianapolis, IN 46250, US

Establishment Type(s)

Manufacture Device in the United States for Export Only

Owner / Operator

Roche Diagnostics Operations Inc. (Owner Number: 9039767)

Owner / Operator Contact Address

9115 Hague Road, Indianapolis, IN 46250, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

cobas transfer - RRF Heam,Coag 10 cobas bge link cobas Academy cobas IT 1000 c8100 PXT c8100 CLW c8100 TLJ c8100 SLL c8100 Type Alpha cobas 8100 OBS cobas 8100 ACU c8100 RFX c8100 Model Beta cobas 8100 connection kit cobas 8100 URF . c8100 SCM cobas 8100 RSF c8100 CLO Universal Connection Unit Bulk Loader for cobas p 471 Laser LLD centrifuge unit cobas connection module c8100 Beta c8100 SLR Aliquot Tip Loader cobas 8100 AOB c8100 CRW cobas 8100 BCL turn unit conveyor unit c8100 BCL cobas 8100 Model Alpha cobas 8100 BCL - FBT Modification kit cobas 8100 Signal Tower c8100 BRF Sorting System cobas p312(Kolibri) Bulk Loader Module for p512/612 LASER LLD INCL QSI/TTI cobas p501/p701 c8100 CRO Liquid Level Detection UPGR Kit cobas p701 cobas p 512 System Software cobas p 612 system cobas p671 output unit CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE cobas 8100 RSS Roche cobas Liat Module- IT 1000 Bi-directional driver STD INSTR P671 TTI W/O BC READ UN 115V p501/p701 Systems STD INSTR P471 TTI W/O BC READ UN 115 PComm ver 1.12.11 cobas Infinity v2.2.3 RSD Systems 770-1-CCM-AOB v1.1 VS Systems CCM AOB sw ver 13 cobas Infinity v2.3.3 SW COBAS P 312 VERSION 1.1.1 SW PATCH_P312_1.1.3_UPD.TAR.BZ2 STD INSTR P612 LASER LLD QSI REC w/o CCM Online Adapter 1.5 cobas Infinity v2.3.2 STD INSTR P671 TTI BC READING UN 115V cobas Infinity v2.2.1 COBAS P612 PRE-ANALYTICAL SYSTEM W/O CCM RSA Systems cobas8800B cobas p471 STD INSTR P471 TTI BC READING UNIT 115V cobas infinity sw v2.5.3 CLAS Systems cobas infinity MPA Systems cobas Infinity 3rd Party Drivers IT 1000 Operator Data driver ver. 1.1.2 HemoCue 201DM Glu RT module STD INSTR P612 LASER LLD QSI 3HHT CCM 713-2-cobase 8100 v1.5 CoaguChek Link Tier 1 cobas Infinity v2.2 IT 1000- PCOmmunicator .bat file 579-2-RSA Dynamic Interface v1.1 c8100 SW 03-09 cobas Infinity v2.2.2 c8100 Wright Patterson Air Force Base US cobas IT 1000 i-STAT/DE module HemoCue 201DM Glu module Coaguchek Link cobas infinity insights license PComm ver. 1.12.12 with script_1.12.13 MPA EVO Analycer connection Host CIT1k 3.9 CoaguChek Link Tier 2 Comm Server 1.11.3725 BCM for cobas 8100 Driver Framework 3.1.8915 Power Supply Unit cobas Infinity sw v2.5.1 cobas infinity POC IT solutions IT 1000 All in one installer STD INSTR P512 LASER LLD QSI REC w/o CCM cobas infinity core license cobas IT 1000 Operator Sync CoaguChek Link Tier 3 Piccolo Xpress module cobas p 501/ p 701 system software CCM cobas c 513 Connection Unit Linear Buffer Unit HemoCue 201DM Hb module cobas p 501/701 System Software CCM Address Extension Unit Data Innovations Instrument Manager Modular Connection Unit cobas infinity sw v317 Cobas 6000 Connection Unit CONVEYOR 2 Unit CONVEYOR 4 Unit SW c8000 data manager 168 HST Connection Unit Add-On Buffer Unit NAVIFY Remote Monitor OUTPUT UNIT Cobas 8000 Connection Unit CONVEYOR 3 Unit CONVEYOR 1 Unit CCM Bidirectional Interface TURN UNIT cobas Infinity Central Lab CCM Backend Connection Unit cobas 8100 System Software cobas BLIM for p471/p671/BCM cobas BLIM for p512/p612 ConKit cobas BLIM to p x71 B-Gate Interface cobas p 512 system cobas infinity POC CCM Vertical Overhead Conveyor Unit (1m) cobas transfer - RRF Urine 10 CD SYSTEM SW p 612 SP 2.1.1 navify® Lab Operations Accu-Chek Care cobas infinity POC remote access CCM Vertical Turntable Unit Accu-Chek 360° Diabetes Management System Professional CCM Vertical Power Box Unit Universal Connection Module (UCM2) CD SW multilingual_software_2.1.1 CD SYSTEM SW p 512 SP 2.1.1 navify POC Operations Accu-Chek Care (HCP) Kidney KFRE Algorithm navify Quality Control CCM Vertical Elevator Unit Accu-Chek Smart Pix Software cobas transfer - RRF Coag 5 cobas p 501 Post-Analytical Unit cobas p (701) POST ANALYTICAL ACCU-CHEK FASTCLIX KIT CANADA ACCU-CHEK SMART VIEW 100CT STRIP 24/CS ACCU-CHEK SMART VIEW 50CT STRIP 36/CS ACCU-CHEK NANO SAMPLE KIT 16/CASE ACCU-CHEK SMART VIEW 25 + 5 STRIP 36/CS ACCU-CHEK NANO RETAIL KIT 8/CASE ACCU-CHEK NANO METER ONLY ACCU-CHEK Nano SmartView Blood Glucose Monitoring System ACCU-CHEK SMART VIEW CONTROL 2 ACCU-CHEK SMART VIEW 25CT STRIP 36/CS ACCU-CHEK SMART VIEW MED BEN STRIP 36/CS ACCU-CHEK SMART VIEW MAIL ORDER STRIP 36 ACCU-CHEK SMART VIEW 10CT STRIP ACCU-CHEK SMART VIEW CONTROL 6/CS ACCU-CHEK NANO SAMPLE KIT DSGNR 16/CASE ACCU-CHEK SmartView Control Solutions ACCU-CHEK Nano Meter ACCU-CHEK SmartView Test Strip ACCU-CHEK NANO RETAIL KIT DSGNR 8/CASE ACCU-CHEK GUIDE MG/DL KIT Accu-Chek Guide Test Strip 100 CT 24/CS ACCU-CHEK GUIDE MAIL ORDER 50 CT ACCU-CHECK Guide Blood Glucose Monitoring System ACCU-CHEK GUIDE MED BEN 50 CT Accu-Chek Guide Test Strip 50 CT 36/CS ACCU-CHEK GUIDE 100CT STRIP 24/CS Accu-Chek Guide Retail Kit mg/dL (US) ACCU-CHEK GUIDE METER ONLY MG/DL US ACCU-CHEK Guide Control Solutions ACCU-CHEK GUIDE 25CT STRIP 36/CS ACCU-CHEK GUIDE 10CT STRIP 36/CS ACCU-CHEK GUIDE MG/DL METER 923 (US) ACCU-CHEK GUIDE MG/DL M-O Accu-Chek Guide Test Strip 10 CT 36/CS Accu-CHEK GUIDE 2-LEVEL CONTROLS US ACCU-CHEK GUIDE 50CT HN 36/CS ACCU-CHEK GUIDE 50CT STRIP 36/CS ACCU CHEK GUIDE HCP SAMPLE LAUNCH BOX ACCU-CHEK GUIDE RETAIL KIT MG/DL ACCU-CHEK GUIDE 2-LEVEL CONTROLS US ACCU-CHEK GUIDE RETAIL KIT FCN MG/DL US Accu-Chek Guide Blood Glucose Monitoring System Accu-Chek Guide Sample Kit FCN MG/DL US ACCU-CHEK GUIDE CASH VALUE KIT SC MG/DL ACCU-CHEK GUIDE CASH US 60CT STRIP ACCU-CHEK GUIDE CASH US 30CT STRIP Accu-chek Guide Me ACCU-CHEK PERFORMA INT'L CONTROLS ACCU-CHEK INSTANT LIN KIT INTL ACCU-CHEK INSTANT CONTROLS INTL II ACCU-CHEK INSTANT CONTROLS INTL I ACCU-CHEK GUIDE 2-LEVEL CONTROLS INTL3 ACCU-CHEK Inform II Meter ACCU-CHEK Inform II Control Solutions ACCU-CHEK Inform II Test Strip ACCU-CHEK Inform II Linearity Test Kit ACCU-CHEK Inform II Meter Kit + RF ACCU-CHEK Inform II Blood Glucose Monitoring System ACCU-CHECK INFORM II US 50CT 72/CS F2 ACCU-CHEK INFORM II CNTRL US 6/CS ACCU-HEK LINEARITY KIT U.S. ACCU-CHEK Inform II System A/C Inform II Base Unit Kit Accu-Chek Performa Accu-Chek Guide Me Accu-Chek Instant Accu-Chek Aviva Accu-Chek Guide Accu-Chek Instant S IWL2020 Blood Glucose Monitoring System ReliOn Platinum IWL2020 test strips Accu-Chek Performa test strips Accu-Chek Guide test strips Accu-Chek Guide Blood Glucose Monitoring System Accu-Chek Inform II test strips Accu-Chek Aviva test strips Accu-Chek Instant test strips

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JQP	Calculator/Data Processing Module, For Clinical Use	Clinical Chemistry	Class 1	862.2100	2008-06-12
QRL	Multiple Use Blood Lancet For Single Patient Use Only	General, Plastic Surgery	Class 2	878.4850	2023-04-21
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2016-10-14
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	Class 2	862.1345	2016-10-14
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2016-10-17
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	Class 2	862.1345	2016-10-17
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2016-10-17
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2018-12-19
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2020-05-05
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2012-10-23
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	Class 2	862.1345	2012-10-23
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2012-10-23
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2018-05-07
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2022-05-12
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	Class 2	862.1345	2018-05-07

Official Correspondent

Brian Frazier

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Roche Diagnostics Operations Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3010900203	Roche Diagnostics S.L.	Sant Cugat del Valles Barcelona, ES
3039321686	Roche Lumira Dx Stirling	Manor Loan Stirling, GB
3039322300	Roche Lumira Dx Bathgate	Bathgate Scotland, GB
3011806823	Roche Diabetes Care GmbH	Mannheim Baden-Wurttemberg, DE
3020917535	Roche Diagnostics (Suzhou) Ltd.	Suzhou Jiangsu, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K781173	Instrumentation Laboratory CO	COMPUTER INTERFACE IL 814	1978-09-14
K150396	Apex BioTechnology Corp.	Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips	2015-10-14
K150833	Andon Health Co, Ltd.	iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring System, iHealth BG5L wireless Smart Gluco-Monitoring System	2015-12-04
K973662	Boehringer Mannheim Corp.	ACCU-CHEK(R)COMPLETE SYSTEM/METER & ACCU-CHEK ADVANTAGE TEST STRIPS/ACCU-CHEK ADVANTAGE H TEST STRIPS	1997-12-15
K103744	Quantimetrix Corp.	DROPPER A1C DIABETES CONTROL	2011-05-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-04	Misys Healthcare Systems	1	Calculator/Data Processing Module for Clinical Use
Z-0026-2025	Becton Dickinson & Co.	1	BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30- IVD standalone laboratory software solution providing data management and workflow management functionality across locations where clinical diagnostic activities take place. Catalog Number: 444150
Z-0004-2009	Lifescan Inc	2	One Touch Ultra Test Strips, part number 020-994-02, manufactured by LifeScan Inc, Milpitas, CA, 25 count. Intended to be used for quantitative measurement of glucose in fresh capillary whole blood. Intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. Intended for use on the finger, arm, or palm.
Z-0042-06	Abbott Laboratories Medisense Products	2	FreeStyle FLASH Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0043-06	Abbott Laboratories Medisense Products	2	Tracker Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502

Similar Registrations

Registration Number	Establishment Name	Location
3004032053	Abbott S.r.l.	Milan Lombardy, IT
3013922172	INDIGO BIOAUTOMATION, INC.	Carmel, IN, US
3012436569	NATIONAL TECHNOLOGY FOR SOFTWARE	Cairo Al Qahirah, EG
3015426626	Aclarion, Inc.	Broomfield, CO, US
3030413550	LIFE DATA LAB, LLC	New York, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011393376. Last updated year: 2026. Please use registration number 3011393376 when referencing this establishment in official correspondence.