PEBBLE qcLAMP Platform
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I N S T R U C T I O N S F O R U S E
v1.1 10.08.2021
16.
SAFETY AND DISCLOSURE OF RESIDUAL RISKS
The Risk Management Process for BIOPIX-T complies with the ISO 14971:2019. Therefore,
the Pebble qcLAMP Platform does not carry any residual risks.
All the identified risks have been accepted by the BIOPIX-T by mitigation control
measures.
Furthermore, Pebble qcLAMP Platform has successful pass all the safety tests and
complies with the requirements IEC 61010-2-101:2018 and IEC 61326-2-6:2012.
17.
REFERENCES
[1]
G. Papadakis et al., “Real
-time colorimetric LAMP methodology for quantitative nucleic
acids detection at the point-of-
care,” no. 89, pp. 1–
20, 2020, doi: 10.1101/2020.07.22.215251.
[2]
World Health Organization (WHO), “Coronavirus disease 2019 (2019
-nCOV) Situation
Report
–
11,” WHO Bull., no.
January 31, pp. 1
–
7, 2020.
[3] COV19 qcLAMP kit, Instructions for Use, BIOPIX-T
[4] Flu A qcLAMP kit, Instructions for Use, BIOPIX-T
18.
SYMBOLS EXPLAINED
Symbol
Title/Meaning/Referent
Function/description
Website
To identify the website of the manufacturer.
