Page 6 - HSP COVID Rapid Testing Booklet RV6

May 27, 2020

To Whom It May Concern,

Biolab Sciences has partnered with two separate lab manufacturers to manufacture the 2019-nCov
IgG/IgM Rapid Test Cassette Single Use Kit. The two labs are Alfa Scientific Designs/Clarity and Spring
Healthcare Services Labs. The FDA registration verification can be obtained through the following link
https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-testing-sars-cov-2.
The use of these test in the United States is covered under the Emergency Use Authorization (EUA).
Both tests also maintain valid CE Marks (European approvals).

Under the provisions of the EUA, BioLab Sciences is able to manufacture and distribute the 2019-nCov
IgG/IgM Rapid Test Cassette Single Use Kit while the EUA is issued, and until formal approval is earned.
A formal approval must be achieved before the expiration of the EUA in order to continue the
manufacturing and distribution of the tests post EUA in the United States.

Biolab Sciences and its lab partners do not sell directly to healthcare organizations, and leverage
national and international distributors and resellers to deliver products to customers domestically and
internationally. Hensler Surgical Technologies is a preferred distributor and reseller in the United States
and is fully licensed and authorized to act on behalf of BioLab Sciences when representing the 2019-
nCov IgG/IgM Rapid Test Cassette Single Use Kit.

If any additional information is required as it pertains to this proclamation, please do not hesitate to
contact us at:

Jaime Leija
Chief Commercialization Officer
Jleija@biolabsciences.net
480-935-3744