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
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