FDA-Device2022-07-20Class II
Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use on VITROS¿ ECi/ECiQ/3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems. Product Code: 6199960
Ortho-Clinical Diagnostics, Inc.
Hazard
On-Analyzer Stability (OAS) time, supported for 6 weeks; not 8 weeks as is currently stated in the Instructions For Use (IFU).
Sold states
Worldwide distribution - US Nationwide and the countries of Colombia, India, Singapore.
Affected count
20858
Manufactured in
100 Indigo Creek Dr, Rochester, NY, United States
Products
Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use on VITROS¿ ECi/ECiQ/3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems. Product Code: 6199960
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1367-2022Don't want to check this manually?
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