Roche Sequencing Solutions Inc

FDA Filings

This page includes the latest FDA filings for Roche Sequencing Solutions Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3009731198
FEI Number3009731198
NameRoche Sequencing Solutions Inc.
Owner & OperatorRoche Diagnostics Operations Inc.
Contact Address9115 Hague Road
Indianapolis IN 46250 US
Official Correspondent
  • Michael Leslie
  • x-317-5214343-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2821 Scott Blvd.
Santa Clara, CA 95050 US
Establishment Type
  • Manufacture Device in the United States for Export Only
  • Develop Specifications But Do Not Manufacture At This Facility



FDA Filings

Device
Company
DeviceDate
Roche Sequencing Solutions Inc. [Roche Diagnostics Operations Inc.]
Ariosa DANSR Library Rgt Kit Box 2 CE-IVD2018-05-04
Roche Sequencing Solutions Inc. [Roche Diagnostics Operations Inc.]
Ariosa DANSR Library Rgt Kit Box 1 CE-IVD2018-05-04
Roche Sequencing Solutions Inc. [Roche Diagnostics Operations Inc.]
Ariosa DANSR Detect Rgt Kit Box 4 CE-IVD2018-05-04
Roche Sequencing Solutions Inc. [Roche Diagnostics Operations Inc.]
Ariosa DANSR Detect Rgt Kit Box 3 CE-IVD2018-05-04
Roche Sequencing Solutions Inc. [Roche Diagnostics Operations Inc.]
Ariosa DANSR Detect Rgt Kit Box 1 CE-IVD2018-05-04
Roche Sequencing Solutions Inc. [Roche Diagnostics Operations Inc.]
cobas p 680 START-UP KIT2001-04-23
Roche Sequencing Solutions Inc. [Roche Diagnostics Operations Inc.]
SW cobas omni UCT 3.12001-04-23
Roche Sequencing Solutions Inc. [Roche Diagnostics Operations Inc.]
PC/CC-CUPS2001-04-23
Roche Sequencing Solutions Inc. [Roche Diagnostics Operations Inc.]
MagNa Pure Waste accessories2001-04-23
Roche Sequencing Solutions Inc. [Roche Diagnostics Operations Inc.]
MagNa Pure RXN TIPS-LARGE2001-04-23
Roche Sequencing Solutions Inc. [Roche Diagnostics Operations Inc.]
MagNa Pure REAGENT TUB LID (Large)2001-04-23
Roche Sequencing Solutions Inc. [Roche Diagnostics Operations Inc.]
MagNa Pure Lyser Rotor2001-04-23
Roche Sequencing Solutions Inc. [Roche Diagnostics Operations Inc.]
MagNa Pure Liquid Waste Funnel2001-04-23
Roche Sequencing Solutions Inc. [Roche Diagnostics Operations Inc.]
MagNa Pure LC Cool Block, Sample Carousel2001-04-23
Roche Sequencing Solutions Inc. [Roche Diagnostics Operations Inc.]
MagNa Pure LC 2.0 Instrument2001-04-23
Roche Sequencing Solutions Inc. [Roche Diagnostics Operations Inc.]
MagNa Pure Compact Tube Rack2001-04-23
Roche Sequencing Solutions Inc. [Roche Diagnostics Operations Inc.]
MagNa Pure Compact Elution Tube Rack2001-04-23
Roche Sequencing Solutions Inc. [Roche Diagnostics Operations Inc.]
MagNa Pure Compact Drop catcher2001-04-23
Roche Sequencing Solutions Inc. [Roche Diagnostics Operations Inc.]
MagNa Pure Compact Drip Tray2001-04-23
Roche Sequencing Solutions Inc. [Roche Diagnostics Operations Inc.]
MagNa Pure Compact Cartridge Rack2001-04-23
Roche Sequencing Solutions Inc. [Roche Diagnostics Operations Inc.]
MagNa Pure 96 Waste Rack IVD2001-04-23
Roche Sequencing Solutions Inc. [Roche Diagnostics Operations Inc.]
MagNa Pure 96 Reagent Rack IVD2001-04-23
Roche Sequencing Solutions Inc. [Roche Diagnostics Operations Inc.]
MagNa Pure 96 Purification Rack IVD2001-04-23
Roche Sequencing Solutions Inc. [Roche Diagnostics Operations Inc.]
MagNa Lyser 115V2001-04-23
Roche Sequencing Solutions Inc. [Roche Diagnostics Operations Inc.]
MagNA Pure 24 Tip Park/Piercing Tool2001-04-23
Roche Sequencing Solutions Inc. [Roche Diagnostics Operations Inc.]
MagNA Pure 24 Piercing Tool2001-04-23
Roche Sequencing Solutions Inc. [Roche Diagnostics Operations Inc.]
MPLC Tub Lid (Large)2001-04-23
Roche Sequencing Solutions Inc. [Roche Diagnostics Operations Inc.]
MPLC TUB LID SEAL2001-04-23
Roche Sequencing Solutions Inc. [Roche Diagnostics Operations Inc.]
MPLC TUB LID (Small, Medium)2001-04-23
Roche Sequencing Solutions Inc. [Roche Diagnostics Operations Inc.]
MPLC Reagent Tub (SMALL)2001-04-23
Roche Sequencing Solutions Inc. [Roche Diagnostics Operations Inc.]
MPLC Reaction Tip (small)2001-04-23
Roche Sequencing Solutions Inc. [Roche Diagnostics Operations Inc.]
MPLC O-Ring Maintenance Kit2001-04-23
Roche Sequencing Solutions Inc. [Roche Diagnostics Operations Inc.]
MPLC Greasing Set2001-04-23
Roche Sequencing Solutions Inc. [Roche Diagnostics Operations Inc.]
MPLC CB, Reaction Tubes2001-04-23
Roche Sequencing Solutions Inc. [Roche Diagnostics Operations Inc.]
MPLC CB, 96-well PCR Plate2001-04-23
Roche Sequencing Solutions Inc. [Roche Diagnostics Operations Inc.]
MP Compact Waste Tank2001-04-23
Roche Sequencing Solutions Inc. [Roche Diagnostics Operations Inc.]
MAGNAPURE ACCESSORIES2001-04-23
Roche Sequencing Solutions Inc. [Roche Diagnostics Operations Inc.]
Lightcycler O-Ring2001-04-23
Roche Sequencing Solutions Inc. [Roche Diagnostics Operations Inc.]
Lightcycler Color Compensation Set2001-04-23
Roche Sequencing Solutions Inc. [Roche Diagnostics Operations Inc.]
Lightcycler 2 Sample Carousel2001-04-23
Roche Sequencing Solutions Inc. [Roche Diagnostics Operations Inc.]
Lightcycler 2 Centrifuge2001-04-23
Roche Sequencing Solutions Inc. [Roche Diagnostics Operations Inc.]
LIGHTCYCLER CLASSIC ROTOR UPGRADE KIT2001-04-23
Roche Sequencing Solutions Inc. [Roche Diagnostics Operations Inc.]
LIGHTCYCLER ACCESSORIES2001-04-23
Roche Sequencing Solutions Inc. [Roche Diagnostics Operations Inc.]
LC Carousel Centrifuge 2.0 Bucket 2.12001-04-23
Roche Sequencing Solutions Inc. [Roche Diagnostics Operations Inc.]
Instrument Check2001-04-23
Roche Sequencing Solutions Inc. [Roche Diagnostics Operations Inc.]
ISD Sample PT Elecsys cobas e 1002001-04-23
Roche Sequencing Solutions Inc. [Roche Diagnostics Operations Inc.]
INSTC, 130Tests, cobas c5032001-04-23
Roche Sequencing Solutions Inc. [Roche Diagnostics Operations Inc.]
Clot Catcher Pro [100 PCS]2001-04-23
Roche Sequencing Solutions Inc. [Roche Diagnostics Operations Inc.]
Cell Set cobas C3112001-04-23
Roche Sequencing Solutions Inc. [Roche Diagnostics Operations Inc.]
Carry-over Needle Assessment2001-04-23
Roche Sequencing Solutions Inc. [Roche Diagnostics Operations Inc.]
CONA, 100Tests, cobas c5032001-04-23
Roche Sequencing Solutions Inc. [Roche Diagnostics Operations Inc.]
CLOT CATCHER [250 PC]2001-04-23
Roche Sequencing Solutions Inc. [Roche Diagnostics Operations Inc.]
Avenio Millisect System 2.02001-04-23
Roche Sequencing Solutions Inc. [Roche Diagnostics Operations Inc.]
AVENIO MILLISECT System2001-04-23

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