LumiraDx SARS-CoV-2, Руководство пользователя

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Document Name: SARS-CoV-2 Antigen (Ag) Quality Controls Pack Insert
Document Number: S-COM-DOUT-00132 Revision: 2
This document is controlled and released electronically in Grand Avenue. Hard copies are uncontrolled and should not be relied upon for
the most recent version unless formally issued and stamped by QA. Created with S-QMS-TEM-00002
consequential damages, including, without limitation, loss of business, profits, data or revenue, even if
a party receives notice in advance that these kinds of damages might result.
The Limited Warranty above shall not apply if the customer has subjected the LumiraDx SARS-CoV-2
Ag Test Strips and Controls Pack to physical abuse, misuse, abnormal use, use inconsistent with the
LumiraDx Platform User Manual, SARS-CoV-2 Ag Test Product Insert or SARS-CoV-2 Ag Quality
Controls Pack Insert, fraud, tampering, unusual physical stress, negligence or accidents. Any warranty
claim by Customer pursuant to the Limited Warranty shall be made in writing within the applicable
Limited Warranty period.
Intellectual property: The LumiraDx Instrument, Test Strips and all provided LumiraDx documentation
(‘Products’) are protected by law. The Intellectual Property of the LumiraDx Products remains at
LumiraDx. Details of relevant Intellectual Property regarding our products can be found at
lumiradx.com/IP. Test Strips contained herein include reagents provided under license right from
TriLink BioTechnologies LLC.
Legal notices: Copyright © 2020 LumiraDx UK and affiliates. All rights reserved. LumiraDx and Flame
logo are protected trademarks of LumiraDx International LTD. Full details of these and other
registrations of LumiraDx can be found at lumiradx.com/IP. All other trademarks are the property of
their respective owners.
Manufacturer information. LumiraDx UK Ltd, Dumyat Business Park, Alloa, FK10 2PB, UK.
Registration Number: 09206123
LumiraDx US Office . 221 Crescent St, Suite 502, Waltham, MA 02453. Telephone: (617) 621-9775
In the USA, this test has not been FDA cleared or approved; this test has been authorized by FDA
under an EUA for use by authorized laboratories; use by laboratories certified under the CLIA, 42 U.S.C.
§263a, that meet requirements to perform moderate, high or waived complexity tests. This test is
authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA
Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. This test has been
authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.
In the USA, this test is only authorized for the duration of the declaration that circumstances exist
justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of
the virus that causes COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act,
21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
Date of revision: 08/2020