Page 2 - HSP COVID Rapid Testing Booklet RV6
P. 2
May 12, 2020
To Whom It May Concern,
Spring Healthcare Laboratories and BioLab Sciences have registered the 2019-nCov IgG/IgM Rapid Rest
Cassette Single Use Kit with the U.S Food and Drug Administration. The registration number is
PEUA200955. The use of this test in the United States is covered under the Emergency Use
Authorization (EUA). Our product also has a valid CE mark with the European Union, REF: SP-400; Class:
Other Device of IVDD 98/79/EC; Conformity Assessment Route: IVDD 98/79/EC Annex III; EDMA Code
15-70-9090000.
Both BioLab Sciences and Spring Healthcare Laboratories 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. Hensler Surgical
Technologies is fully licensed and authorized to act on behalf of BioLab Sciences and Spring Healthcare
Laboratories when representing the 2019-nCov IgG/IgM Rapid Rest 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
Respectfully,
Jaime Leija
Chief Commercialization Officer