Page 9 - HSP COVID Rapid Testing Booklet RV6
P. 9
May 20, 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 Alpha Scientific Designs, Inc and Spring Healthcare
Services Labs. The FDA registration number for Spring Healthcare is PEUA200955 (registered on May 4, 2020).
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).
The following are estimated turnaround times for orders based on the size of the orders. Large/bulks orders
exceeding 10,000 tests are processed on a first in, first out basis. All production for large/bulk orders are
scheduled in the production que based on the acceptance of a formal letter of intent and a down payment for
the order.
25 - 1,500 tests: Next day
1,525 - 5000 tests: 3 - 5 days
5,000 - 9975 tests: 5-7 days
10,000 – 49,999 tests: Average 10 days
50,000 – 199,999 tests: Average 14 days
200,000 – 499,000 tests: Average 21 days
500,000 – 2 million tests: Average 28 days
2 million plus: Mutually agreed upon fulfillment schedule
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
480-935-3744
Chief Commercialization Officer
Jleija@biolabsciences.net
Respectfully,
Jaime Leija
Chief Commercialization Officer