5 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/Catalog Number: 6802783 (New), 6802914 (Certified/Refurbished), 6904000 (China) Software Version: version 3.8.0 or higher Product Description: In vitro diagnostic chemistry analyzer. FDA 3 letter product code: JJE Component: no, not a component
FDA Enforcement
Class II
·Ongoing·Ortho-Clinical Diagnostics, INc.·January 29, 2025
VITROS 3600 Immunodiagnostic System Product Code 6802783 and Refurbished Product Code 6802914 Running Software Version 3.8.0
FDA Enforcement
Class II
·Ongoing·Ortho-Clinical Diagnostics, Inc.·December 20, 2023
VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)
FDA Enforcement
Class II
·Ongoing·Ortho-Clinical Diagnostics, Inc.·March 13, 2024
VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)
FDA Enforcement
Class II
·Ongoing·Ortho-Clinical Diagnostics, Inc.·March 13, 2024
Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1 Chemistry System (Refurbished) (Product Code 6801890), VITROS 3600 Immunodiagnostic System (Product Code 6802783), VITROS 3600 Immunodiagnostic System (Refurbished) (Product Code 6802914), VITROS 4600 Chemistry System (Product Code 6802445), VITROS 4600 Chemistry System (Refurbished) (Product Code 6900440), VITROS 5600 Integrated System (Product Code 6802413), VITROS 5600 Integrated System (Refurbished) (Product Code 6802915), VITROS XT 3400 Chemistry System (Product Code 6844458), and VITROS XT 7600 Integrated System (Product Code 6844461)
FDA Enforcement
Class II
·Ongoing·Ortho-Clinical Diagnostics, Inc.·October 11, 2023