Roche Diagnostics Automation Solutions G M B H

FDA Filings

This page includes the latest FDA filings for Roche Diagnostics Automation Solutions G M B H. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3003618481
FEI Number3003618481
NameRoche Diagnostics Automation Solutions GmbH
Owner & OperatorRoche Diagnostics Operations Inc.
Contact Address9115 Hague Road
Indianapolis IN 46250 US
Official Correspondent
  • Michael Leslie
  • x-317-5214343-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressMaybachstrasse 30
Waiblingen Baden-Wurttemberg, 71332 DE
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
turn unit2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
p501/p701 Systems2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
output unit2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
conveyor unit2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
cobas8800B2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
cobas p7012008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
cobas p6712008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
cobas p501/p7012008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
cobas p4712008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
cobas p 612 system2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
cobas p 612 pre-analytical system2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
cobas p 512 pre-analytical system2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
cobas p 512 System Software2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
cobas p 501/701 System Software2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
cobas p 501/ p 701 system software2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
cobas infinity2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
cobas infinity sw v3.01.072008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
cobas infinity sw v2.5.32008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
cobas infinity insights license2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
cobas infinity core license2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
cobas infinity POC IT solutions2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
cobas connection module2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
cobas bge link2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
cobas Infinity v2.3.32008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
cobas Infinity v2.3.22008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
cobas Infinity v2.22008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
cobas Infinity v2.2.32008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
cobas Infinity v2.2.22008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
cobas Infinity v2.2.12008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
cobas Infinity sw v2.5.12008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
cobas Infinity 3rd Party Drivers2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
cobas IT 10002008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
cobas IT 1000 i-STAT/DE module2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
cobas IT 1000 Operator Sync2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
cobas Academy2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
cobas 8100 connection kit2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
cobas 8100 URF .2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
cobas 8100 Signal Tower2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
cobas 8100 RSS2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
cobas 8100 RSF2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
cobas 8100 OBS2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
cobas 8100 Model Alpha2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
cobas 8100 BCL2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
cobas 8100 BCL - FBT Modification kit2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
cobas 8100 AOB2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
cobas 8100 ACU2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
centrifuge unit2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
c8100 Wright Patterson Air Force Base US2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
c8100 Type Alpha2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
c8100 TLJ2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
c8100 SW 03-092008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
c8100 SLR2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
c8100 SLL2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
c8100 SCM2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
c8100 RFX2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
c8100 PXT2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
c8100 Model Beta2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
c8100 CRW2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
c8100 CRO2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
c8100 CLW2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
c8100 CLO2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
c8100 Beta2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
c8100 BRF2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
c8100 BCL2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
Vantage2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
VS Systems2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
VANTAGE 2.5.2 Software Installer2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
Universal Connection Unit2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
Sorting System cobas p312(Kolibri)2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
SW PATCH_P312_1.1.3_UPD.TAR.BZ22008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
SW COBAS P 312 VERSION 1.1.12008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
STD INSTR P671 TTI W/O BC READ UN 115V2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
STD INSTR P671 TTI BC READING UN 115V2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
STD INSTR P612 LASER LLD QSI REC w/o CCM2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
STD INSTR P612 LASER LLD QSI 3HHT CCM2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
STD INSTR P471 TTI W/O BC READ UN 1152008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
STD INSTR P471 TTI BC READING UNIT 115V2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
Roche cobas Liat Module- IT 1000 Bi-directional driver2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
RSD Systems2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
RSA Systems2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
Piccolo Xpress module2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
PComm ver. 1.12.12 with script_1.12.132008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
PComm ver 1.12.112008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
Online Adapter 1.5.0.02008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
MPA Systems2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
MPA EVO Analycer connection2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
Liquid Level Detection UPGR Kit2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
Laser LLD2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
LASER LLD INCL QSI/TTI2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
IT 1000- PCOmmunicator .bat file2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
IT 1000 Operator Data driver ver. 1.1.22008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
IT 1000 All in one installer2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
Host CIT1k 3.0.92008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
HemoCue 201DM Hb module2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
HemoCue 201DM Glu module2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
HemoCue 201DM Glu RT module2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
Driver Framework 3.1.0.89152008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
Data Innovations Instrument Manager2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
Comm Server 1.11.0.37252008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
Coaguchek Link2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
CoaguChek Link Tier 32008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
CoaguChek Link Tier 22008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
CoaguChek Link Tier 12008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
COBAS P612 PRE-ANALYTICAL SYSTEM W/O CCM2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
CLAS Systems2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
CCM AOB sw ver 1.032008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
Bulk Loader for cobas p 4712008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
Bulk Loader Module for p512/6122008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
BCM for cobas 81002008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
Aliquot Tip Loader2008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
770-1-CCM-AOB v1.1.02008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
713-2-cobase 8100 v1.0.52008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
579-2-RSA Dynamic Interface v1.1.02008-06-12
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
cobas p 680 START-UP KIT2001-04-23
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
SW cobas omni UCT 3.12001-04-23
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
PC/CC-CUPS2001-04-23
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
MagNa Pure Waste accessories2001-04-23
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
MagNa Pure RXN TIPS-LARGE2001-04-23
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
MagNa Pure REAGENT TUB LID (Large)2001-04-23
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
MagNa Pure Lyser Rotor2001-04-23
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
MagNa Pure Liquid Waste Funnel2001-04-23
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
MagNa Pure LC Cool Block, Sample Carousel2001-04-23
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
MagNa Pure LC 2.0 Instrument2001-04-23
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
MagNa Pure Compact Tube Rack2001-04-23
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
MagNa Pure Compact Elution Tube Rack2001-04-23
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
MagNa Pure Compact Drop catcher2001-04-23
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
MagNa Pure Compact Drip Tray2001-04-23
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
MagNa Pure Compact Cartridge Rack2001-04-23
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
MagNa Pure 96 Waste Rack IVD2001-04-23
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
MagNa Pure 96 Reagent Rack IVD2001-04-23
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
MagNa Pure 96 Purification Rack IVD2001-04-23
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
MagNa Lyser 115V2001-04-23
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
MagNA Pure 24 Tip Park/Piercing Tool2001-04-23
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
MagNA Pure 24 Piercing Tool2001-04-23
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
MPLC Tub Lid (Large)2001-04-23
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
MPLC TUB LID SEAL2001-04-23
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
MPLC TUB LID (Small, Medium)2001-04-23
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
MPLC Reagent Tub (SMALL)2001-04-23
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
MPLC Reaction Tip (small)2001-04-23
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
MPLC O-Ring Maintenance Kit2001-04-23
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
MPLC Greasing Set2001-04-23
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
MPLC CB, Reaction Tubes2001-04-23
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
MPLC CB, 96-well PCR Plate2001-04-23
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
MP Compact Waste Tank2001-04-23
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
MAGNAPURE ACCESSORIES2001-04-23
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
Lightcycler O-Ring2001-04-23
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
Lightcycler Color Compensation Set2001-04-23
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
Lightcycler 2 Sample Carousel2001-04-23
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
Lightcycler 2 Centrifuge2001-04-23
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
LIGHTCYCLER CLASSIC ROTOR UPGRADE KIT2001-04-23
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
LIGHTCYCLER ACCESSORIES2001-04-23
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
LC Carousel Centrifuge 2.0 Bucket 2.12001-04-23
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
Instrument Check2001-04-23
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
ISD Sample PT Elecsys cobas e 1002001-04-23
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
INSTC, 130Tests, cobas c5032001-04-23
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
Clot Catcher Pro [100 PCS]2001-04-23
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
Cell Set cobas C3112001-04-23
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
Carry-over Needle Assessment2001-04-23
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
CONA, 100Tests, cobas c5032001-04-23
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
CLOT CATCHER [250 PC]2001-04-23
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
Avenio Millisect System 2.02001-04-23
Roche Diagnostics Automation Solutions GmbH [Roche Diagnostics Operations Inc.]
AVENIO MILLISECT System2001-04-23

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