For technical information related to the AcfS:

U.S. Customers:

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

Outside of the U.S. Customers

The Instructions For Use (IFU), Package Insert and Safety Data Sheets (SDSs) can be accessed at https://www.e-labeling.eu using the below key codes.

Once on the e-labeling website, type in the key code per image instruction below:

Harmony IVD Kit

Instructions For Use: Key-Code ARD9000PI1

Harmony OUS-RUO Kit

Package Insert: Key-Code ARD8000PI1

AcfS Software CE-IVD

Instructions For Use: use Key-Code ARD8010PIFORTE

AcfS OUS-RUO Software

Package Insert: Key-Code ARD8020PIFORTE

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 Aneuploidy CNA, use the Key-Code ARD8000SDS5