2 results
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25ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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V-Twin, REF 6002-800 or 6002-850, SN 18-3304, IVD, (01)03661540600180
FDA Enforcement
Class II
·Ongoing·Vital Scientific N.V.·December 4, 2019
V-Twin, Model # 6002-800, UDI: 03661540600180 Product Usage: An in-vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinical chemistry, monitoring drugs of abuse and in therapeutic drug monitoring.
FDA Enforcement
Class II
·Ongoing·Vital Scientific N.V.·October 2, 2019