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Last updated on: 01/10/2024
QbTest and QbCheck provide clinicians with objective measurements of hyperactivity, impulsivity, and inattention to aid in the clinical assessment of ADHD and in the evaluation of treatment interventions in patients with ADHD. QbTest and QbCheck results should be interpreted by qualified health care professionals.
QbTest and QbCheck shall always be interpreted in combination with other clinically relevant information, such as a clinical interview and/or standard symptom scales.
QbTest and QbCheck are indicated to be used to aid in the clinical assessment of ADHD and in the evaluation of treatment interventions in patients with ADHD. QbTest and QbCheck results should be interpreted by qualified health care professionals. For prescription use only.
Individuals between 6 years to 60 years of age who are undergoing ADHD diagnostic process (assessment), who already have been diagnosed or are under treatment.
Healthcare professionals who can prescribe the tests, administer the tests, and interpret test results. Eg, Doctors, Nurses, Clinical Administrators. Test takers can be general population between 6 years to 60 years of age. These are likely to be people who are undergoing ADHD diagnostic process, already diagnosed or under treatment.
Quality Management System
US FDA (21 CR Part 820) compliance
We are fully compliant with the US FDA Quality System Regulation.
ISO 27001
Certificate of Registration of Information Security Management System to ISO 27001:2013 view
ISO 13485:2016
Certificate of Registration of Quality Management System to I.S. EN ISO 13485:2016 view
Product Certifications and Approvals
Australia- Devices listed in ARTG
View the Public ARTG summary view
Europe - CE Marking certificates
View the Certificate of Registration issued by the Medical Products Agency view
United States - FDA 510(k) cleared/PMA approved devices
View our Establishment Registration on the FDA website view
United States - FDA 510(k) cleared/PMA approved devices
QbTest - assessment of ADHD in children view
United States - FDA 510(k) cleared/PMA approved devices
QbTest - assessment of ADHD in adolescents and adults view
United States - FDA 510(k) cleared/PMA approved devices
QbTest - treatment follow up in children, adolescents and adults view
United States - FDA 510(k) cleared/PMA approved devices
QbCheck- assessment and treatment of ADHD in children, adolescents and adults view
ICO Registration Certificate
View our Registration Certificate from the Information Commissioner's Office (ICO) view
Global Regulatory Representatives
ICO Registration Certificate
Australia - Sponsor
EMERGO AUSTRALIA,
Sydney,
Australia
Telephone: +61 2 9006 1662
Website: www.emergobyul.com
Europe
Qbtech AB,
Cardellgatan 1,
11436 Stockholm
Sweden
Telephone: +46 8 790 50 01
Website: www.qbtech.com
United States - Agent
Emergo Group Inc.,
Austin,
Texas
USA
Telephone: +1 512 222 0262
Website: www.emergobyul.com
Data Sub-processors
Amazon Web Services
Server hosting since September 2016
Amazon Web Services provides a highly reliable platform in the cloud that powers hundreds on thousands of businesses around the world.
Braintree Payments
Payments solution services since April 2016
Google
Analytics services. Qbtech supplier since December 2013
NetSuite
Accounting software. Qbtech supplier since January 2023
Salesforce
Customer relationship management solution. Qbtech supplier since January 2023
Zendesk
Customer service solution. Qbtech supplier since November 2013
Microsoft
Cloud Infrastructure for our products and services