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
1.
INTENDED USE
The PEBBLE qcLAMP Platform is a point-of care diagnostic system for providing specimen examination
results for COVID-19 and Influenza A from nasopharyngeal and oropharyngeal swab specimens. The
platform can be used for decentralized testing (doctor’s office, ambulance, hotel
, limited resource
areas etc.).
The PEBBLE qcLAMP Platform is intended to be used only with test kits produced by BIOPIX DNA
TECHNOLOGY P.C.; COV19 qcLAMP kit (CAT#000055) and Flu A qcLAMP kit (CAT#000056).
The PEBBLE qcLAMP Platform is intended to be used by professionals only. It is not intended to be
used by individuals for self-testing.
The platform is intended to be used for testing individuals with or without signs and symptoms
suggestive of COVID-19/Influenza A infection, regardless of gender or age, with the aforementioned
products of BIOPIX DNA TECHNOLOGY P.C.
