FDA-Device2023-08-02Class III
VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use only. For use in verifying the calibration range of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems when used for the quantitative measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP). Catalog Number: 6192257, Lot number: 0090
Hazard
May not meet the stability specifications for shelf life outlined in the Instructions For Use (IFU).
Sold states
US Nationwide distribution in the state of CA.
Affected count
2 units
Manufactured in
100 Indigo Creek Dr, N/A, Rochester, NY, United States
Products
VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use only. For use in verifying the calibration range of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems when used for the quantitative measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP). Catalog Number: 6192257, Lot number: 0090
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2225-2023Don't want to check this manually?
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