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
Ortho-Clinical Diagnostics, Inc.
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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