4
PRECAUTIONS & LIMITATIONS
INTERFERING SUBSTANCES
Interfering substances depend on the concentration. The interfering substances listed
below may produce elevated glucose test results (at or above the concentration levels
noted).
Regulatory Requirements
The Clinical Laboratory Improvement Amendments (CLIA) has classified tests of blood
glucose as tests that are waived. For all entities that conduct one or more tests,
including waived tests on materials derived from the human body for the purpose of
providing information for the diagnosis, prevention or treatment of any disease or
impairment of, or the assessment of the health of human beings, CLIA has stated that
the entity conducting the tests shall meet certain Federal requirements. If any entity
conducts tests for the aforementioned purposes, then the entity, under CLIA, is
considered to be a laboratory and thus must register with the CLIA Program.
KEEP THESE INSTRUCTIONS
IN A SAFE PLACE
Содержание SD Gluco Navii
Страница 1: ......
Страница 2: ......
Страница 36: ...34...
Страница 37: ...35 Attachment 3 QUALITY CONTROL RESULT RECORD SD GlucoNavii Blood Glucose Monitoring System...
Страница 38: ...36 Attachment 3 QUALITY CONTROL RESULT RECORD SD GlucoNavii Blood Glucose Monitoring System...
Страница 40: ...GlucoNavii Distributed by MAXPERT Medical Expert Products for Expert Care...