FDA Registration
Active
🇺🇸 United States
ROCHE DIABETES CARE, INC.
Reg #: 3011393376
·
FEI: 3011393376
·
Expires 2026
Products
9
Proprietary Names
296
Establishment Types
5
Classifications
9
Registration Details
- Registration Name
- ROCHE DIABETES CARE, INC.
- Registration Number
- 3011393376
- FEI Number
- 3011393376
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 9115 Hague Road
- City
- Indianapolis
- State
- IN
- ZIP
- 46250
- Country
- US
Regulatory Submissions
- 510(k) Number
- K113137
- PMA Number
- P160017
Owner / Operator
- Firm Name
- Roche Diagnostics Operations Inc.
- Operator Number
- 9039767
- Address
- 9115 Hague Road
- City
- Indianapolis
- State
- IN
- Postal Code
- 46250
- Country
- US
- Correspondent
- Brian Frazier
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Calculator/Data Processing Module, For Clinical Use | JQP | Class 1 | Clinical Chemistry | No | 2008-06-12 |
| Multiple Use Blood Lancet For Single Patient Use Only | QRL | Class 2 | General, Plastic Surgery | No | 2023-04-21 |
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2016-10-14 |
| Glucose Dehydrogenase, Glucose | LFR | Class 2 | Clinical Chemistry | No | 2016-10-14 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2016-10-17 |
| Automated Insulin Dosing Device System, Single Hormonal Control | OZP | Class 3 | Unknown | No | 2020-09-23 |
| Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | QRK | Class 2 | General, Plastic Surgery | No | 2023-04-21 |
| Calculator, Drug Dose | NDC | Class 2 | Anesthesiology | No | 2016-10-14 |
| Pump, Infusion, Insulin | LZG | Class 2 | General Hospital | No | 2016-10-14 |
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 Inform II test strips
Accu-Chek Aviva test strips
Accu-Chek Instant test strips
Accu-Chek Guide Link Replacement Kit US
Accu-Chek Guide Link FC US MG/DL
Accu-Chek Guide Link Blood Glucose Monitoring System
ACCU-CHEK AVIVA PLUS 25CT STRIP 36/CS
ACCU-CHEK Aviva Meter
ACCU-CHEK AVIVA PLUS METER-ONLY
ACCU-CHEK Aviva Control Solutions
ACCU-CHEK Aviva Plus Test Strip
ACCU-CHEK AVIVA PLUS SAMPLE KIT 16/CASE
ACCU-CHEK AVIVA PLUS SYSTEM
ACCU-CHEK AVIVA PLUS HNP KIT 8/CASE
ACCU-CHEK Aviva Plus Blood Glucose Monitoring System
ACCU-CHEK AVIVA PLUS Retail KIT 8/CASE
ACCU-CHEK AVIVA PLUS Retail KIT 10/CASE
ACCU-CHEK AVIVA PLUS METER ONLY US
ACCU-CHEK AVIVA PLUS SAMPLE KIT 20/CASE
ACCU-CHEK SOFTCLIX KIT CANADA
ACCU-CHEK AVIVA PLUS 50CT STRIP BRK 36/C
ACCU-CHEK AVIVA PLUS 50 HN STP BRK 36/CS
ACCU-CHEK AVIVA PLUS 50 MED-BEN BRK 36/C
ACCU-CHEK AVIVA PLUS 10CT STRIP BRK
ACCU-CHEK AVIVA PLUS 100CT STRP BRK 24/C
ACCU-CHEK AVIVA RETAIL KIT BRK 8/CS
ACCU-CHEK AVIVA PLUS METER ONLY BRK
ACCU-CHEK AVIVA HNP KIT BRK 8/CS
ACCU-CHEK AVIVA SMPL KIT BRK 16/CS
ACCU-CHEK AVIVA PLUS 50 MLRDR BRK 36/CS
ACCU-CHEK Aviva Combo System
ACCU-CHEK PERFORMA 50CT STRIPS EURO 6
ACCU-CHEK AVIVA STRIPS EURO 50 BRK
ACCU-CHEK INFORM II EU2
ACCU-CHEK PERFORMA 50CT STRIP EURO3
ACCU-CHEK PERFORMA 50CT STRIP TK BRK
ACCU-CHEK AVIVA STRIPS EURO 25 BRK
ACCU-CHEK AVIVA STRIPS GERMANY 50 BRK
ACCU-CHEK INFORM II 50 CT UK F2
ACCU-CHEK INFORM II NON-EU LA STRIP
ACCU-CHEK AVIVA STRIPS SPAIN 100 BRK
ACCU-CHEK INFORM II EU1
ACCU-CHEK INFORM II US 50CT 36/CS F2
ACCU-CHEK AVIVA ASPAC STRIP 50CT
ACCU-CHEK PERFORMA 25CT STRIP EURO2
ACCU-CHEK AVIVA STRIPS SPAIN 10 BRK
ACCU-CHEK INFORM II NORDIC 50CT 10/CS F2
LABELED VIAL A/C PERFORMA 10CT STRIP
ACCU-CHEK PERFORMA 50CT STRIP EURO1
ACCU-CHEK INFORM II 50CT C EURO F2 10/CS
ACCU-CHEK PERFORMA 50CT STRIP NON EU
ACCU-CHEK PERFORMA 100CT STRIP EURO1
ACCU-CHEK PERFORMA 50CT STRIP EURO5
ACCU-CHEK PERFORMA 10CT STRIP EURO5
ACCU-CHEK AVIVA STRIPS SPAIN 50 BRK
ACCU-CHEK AVIVA STRIPS EURO 100 BRK
ACCU-CHEK AVIVA STRIPS UK 50 BRK
ACCU-CHEK AVIVA STRIPS GR SI PT 50 BRK
ACCU-CHEK AVIVA STRIPS NORDIC 50 BRK
ACCU-CHEK AVIVA STRIPS GERMANY 10 BRK
ACCU-CHEK INFORM II-DE 50CT 10/CS F2
ACCU-CHEK PERFORMA 50 STRIP AGENCIES BRK
Establishment Types
Manufacture Medical Device
Manufacture Device in the United States for Export Only
Develop Specifications But Do Not Manufacture At This Facility
Repack or Relabel Medical Device
Complaint File Establishment per 21 CFR 820.198