FDA Registration
Active
🇪🇸 Spain
Roche Diagnostics S.L.
Reg #: 3010900203
·
FEI: 3010900203
·
Expires 2026
Products
1
Proprietary Names
160
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Roche Diagnostics S.L.
- Registration Number
- 3010900203
- FEI Number
- 3010900203
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Avda. de la Generalitat 163
- City
- Sant Cugat del Valles Barcelona
- Country
- ES
Owner / Operator
- Firm Name
- Roche Diagnostics Operations Inc.
- Operator Number
- 9039767
- Address
- 9115 Hague Road
- City
- Indianapolis
- State
- IN
- Postal Code
- 46250
- Country
- US
US Agent
- Business Name
- Roche Diagnostics Operations Inc
- Contact Name
- Brian Frazier
- Address
- 9115 Hague Rd
- City
- Indianapolis
- State
- IN
- ZIP
- 46256
- Country
- US
- [email protected]
- Phone
- 317 5214603
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 |
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
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility