3 results
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10ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: (1) 6802413, (2) 6802915
FDA Enforcement
Class II
·Ongoing·Ortho-Clinical Diagnostics, Inc.·July 9, 2025
Brand Name: VITROS; Product Name: VITROS XT 7600 Integrated System; Model/Catalog Number: (1) 6844461, (2) 6272222; Software Version: version 3.2 to version 3.8.3 (all available software versions); Product Description: In vitro diagnostic chemistry analyzer.
FDA Enforcement
Class II
·Ongoing·Ortho-Clinical Diagnostics, Inc.·July 9, 2025
Brand Name: VITROS Product Name: VITROS 4600 Chemistry System Model/Catalog Number: (1) 6802445, (2) 6900440 Software Version: version 3.2 to version 3.8.3 (all available software versions) Product Description: In vitro diagnostic chemistry analyzer.
FDA Enforcement
Class II
·Ongoing·Ortho-Clinical Diagnostics, Inc.·July 9, 2025