For technical information related to the AcfS

U.S. Customers

Technical information and Package Inserts are located at https://dialog1.roche.com/

Outside of the U.S. Customers

For IVDR technical documentation:
Go to https://elabdoc-prod.roche.com
 

For IVDD technical documentation:
Please see below on how to download Instructions for Use, Package Insert, Certificates of Analysis (CofA), and Safety Data Sheets (SDS) from the Qarad site:

Go to:
https://www.rochenipt.qarad.eifu.online

Once on the QARAD website, enter the key code found below into the search bar and click “Search”.

Harmony IVD Kit

Instructions For Use: Key-Code ARD9000PI1

Harmony IVD Kit, Canada Only

Instructions for Use: Key-Code ARD9000PI3CAN
 

Harmony OUS-RUO Kit

Package Insert: Key-Code ARD8000PI1
 

RUO Universal Trisomy Control Kit

Package Insert: Key-Code  ARD9100PI1
 

AcfS Software CE-IVD

Instructions For Use: Key-Code ARD8010PIFORTE
 

AcfS OUS-RUO Software

Package Insert: Key-Code ARD8020PIFORTE
 

CoA

To download CoA, type "ARD" immediately followed by the lot number
 

SDSs:

For Library Box 1, use the Key-Code ARD8000SDS1

For Library Box 2, use the Key-Code ARD8000SDS2

For Detection Box 1, use the Key-Code ARD8000SDS3

For Detection Box 4, use the Key-Code ARD8000SDS4

For FGK0016 (SDS-00108) Kit Service Test Beads Set of 2, use the Key-Code ARD8000SDS6