Product Manual

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2. Cui J, Li F, Shi ZL. Origin and evolution of pathogenic
coronaviruses. Nat Rev Microbiol 2019; 17:181-192.
3. Su S, Wong G, Shi W, et al. Epidemiology, genetic
recombination, and pathogenesis of coronaviruses. Trends
Microbiol 2016;24:490-502.
4. Microbiology Advisory Committee. “COVID19 IgG/IgM RAPID
POCT TESTS”. The Royal College of Pathologists of
Australasia, 1/2020
5. WHO. Coronavirus disease 2019 (COVID-19) Situation Reports.
Available from:
https://www.who.int/emergencies/diseases/novel-coronavirus-
2019/situation-reports
6. Liu L, Liu W et al. A preliminary study on serological assay for
severe acute 2 respiratory syndrome coronavirus 2 (SARS-CoV-
2) in 238 3 admitted hospital patients. Available from:
http://www.medrxiv.org/content/10.1101/2020.03.06.20031856v
1.full.pdf
7. UN - COVID-19 FREQUENTLY ASKED QUESTIONS. Available
from:
https://www.un.org/sites/un2.un.org/files/new_dhmosh_covid-
19_faq.pdf
8. US Food and Drug Administration (FDA). Policy for Diagnostic
Tests for Coronavirus Disease-2019 during the Public Health
Emergency. Immediately in Effect Guidance for Clinical
Laboratories, Commercial Manufacturers, and Food and Drug
Administration Staff. Issued March 16, 2020. Docket Number
FDA-2020-D-0987.
Batch/Lot code
In vitro
diagnostic
medical device
Manufacturer
Catalog
number
Contents sufficient for
< n > tests
Consult
instructions for
use
Caution, consult
accompanying
documents
Do not reuse
Temperature limitation
Salofa Oy
Örninkatu 15, 24100 Salo, Finland
Email:
[e-mail]
Web: www.salofa.com
REF: CD-COV19CW
Version: 02, December 23
rd
, 2020
Marketed by:
CLARITY DIAGNOSTICS LLC
1060 HOLLAND DRIVE, STE A and D
BOCA RATON, FLORIDA 33487, USA
[e-mail]
TECH SUPPORT: 1 -877- 485-7877
www.claritydiagnostics.com
US Technical Support Contact:
TECH SUPPORT: 1 -877- 485-7877
WWW.CLARITYDIAGNOSTICS.COM
[e-mail]