DocuSign Envelope ID: 46220200-AE0A-41F0-80C1-C342A4DFF122
EU Declaration of Conformity
In accordance with EU Regulation 2017/746 of the European Parliament and of the Council of 5 April
2017 on in vitro diagnostic medical devices.
Manufacturer: Roche Molecular Systems, Inc.
1080 US Highway 202 South
Branchburg, NJ 08876
USA
Single Registration Number (SRN) US-MF-000018066
Manufacturer:
Authorized Representative: Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim
Germany
Single Registration Number (SRN) DE-AR-000006262
Authorized Representative:
This declaration is issued under the sole responsibility of Roche Molecular Systems, Inc.
Product Information
Part Number: Product Name: Basic UDI-DI:
cobas® 4800 System Sample Preparation Kit,
05235804190 761333602372AT
960 Tests
cobas® 4800 System Sample Preparation Kit,
05235782190 761333602372AT
240 Tests
06526985190 cobas® Sample Prep Buffer 761333602372AT
cobas® 4800 System Liquid Cytology Preparation
05235839190 761333602372AT
Kit, 960 Tests
cobas® 4800 System Liquid Cytology Preparation
05235812190 761333602372AT
Kit, 240 Tests
06768253190 cobas® 4800 System Lysis Kit 1, 240 Tests 761333602372AT
®
06768270190 cobas 4800 System Lysis Kit 1, 960 Tests 761333602372AT
05235847190 cobas® 4800 System Control Diluent Kit 761333602372AT
®
06768318190 cobas 4800 System Internal Control Kit 1 761333602372AT
05235871190 cobas® 4800 System Wash Buffer Kit, 960 Tests 761333602372AT
05235863190 cobas® 4800 System Wash Buffer Kit, 240 Tests 761333602372AT
MSSOP 7.2.008TMPA - Version: 03 - EU Declaration of Conformity Class A Device Page 1 of 2
DocuSign Envelope ID: 46220200-AE0A-41F0-80C1-C342A4DFF122
Intended Purpose: The cobas® 4800 Sample Preparation Kit, Sample Prep Buffer, Liquid Cytology
Preparation Kit, Lysis Kit, Control Diluent Kit, Internal Control Kit and Wash
Buffer Kit are for use with the cobas® 4800 System.
The cobas® 4800 System is intended to be used as an in-vitro diagnostics
system providing sample preparation, amplification and detection of specific
targets from human samples. It integrates fully automated total nucleic acid
isolation directly from primary and secondary tubes, automated PCR setup, and
real time PCR.
The cobas z 480 analyzer including dedicated software for IVD use is a plate-
based automated amplification and detection system for nucleic acids. The
analyzer is intended to be used as a diagnostics system providing real time
PCR amplification and detection for human samples within the system.
The cobas x 480 instrument and cobas z 480 analyzer are to be used by
trained laboratory professionals.
Risk Class and Class A, as per EU Regulation 2017/746, Annex VIII, Rule 5 (a)
Classification Rule:
Common Not applicable as no Common Specifications exist for the concerned device.
Specifications:
Conformity of the product with EU Regulation 2017/746 and other applicable EU legislation has been
established.
On behalf of Roche Molecular Systems, Inc.
Place: Tucson, AZ Place: Santa Clara, CA
21-Dec-2021 20-Dec-2021
Date: Date:
Jeff Boone Carolyn Glickman
Vice President, Quality Management Director, Regulatory Affairs
MSSOP 7.2.008TMPA - Version: 03 - EU Declaration of Conformity Class A Device Page 2 of 2
