FDA-Device2018-04-04Class II
EasyCAL HbA1c Calibrator; REF 10658 Kit is packaged in a paper box containing 4 vials of 0.25ml of calibrant, one for each calibration level, and an insert sheet.
Medica Corporation
Hazard
Patient results determined using this calibrator lot might deviate up to 20%. Controls might not indicate false values.
Sold states
USA: MI FL CA TX India, Russia, Puerto Rico, N. Mariana Island/Palau.
Manufactured in
5 Oak Park Dr, Bedford, MA, United States
Products
EasyCAL HbA1c Calibrator; REF 10658 Kit is packaged in a paper box containing 4 vials of 0.25ml of calibrant, one for each calibration level, and an insert sheet.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1267-2018Don't want to check this manually?
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