FDA-Device2018-11-14Class III
Pointe Scientific AutoHDL/LDL Cholesterol Calibrator, Catalog Number H7545-CAL - Product Usage: For the calibration of Pointe Scientific s autoHDL and autoLDL Cholesterol Reagent Set in serum or plasma. For in vitro diagnostic use only.
Medtest Holdings, Inc.
Hazard
Vials of the autoHDL/LDL Calibrator were shipped without a vial label.
Sold states
US Nationwide in the states of CA, FL, GA, MI, and OH.
Affected count
22
Manufactured in
5449 Research Dr, Canton, MI, United States
Products
Pointe Scientific AutoHDL/LDL Cholesterol Calibrator, Catalog Number H7545-CAL - Product Usage: For the calibration of Pointe Scientific s autoHDL and autoLDL Cholesterol Reagent Set in serum or plasma. For in vitro diagnostic use only.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0389-2019Don't want to check this manually?
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