2 results
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32ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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BCS XP System: Multipurpose system for in vitro coagulation studies. Product code: 10459330, 10461894, 10470625 - Product Usage: The Behring Coagulation System is an instrument intended to perform quantitative assays of a specific parameters in plasma.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·April 28, 2021
17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-OH Progesterone (17-OHP) in serum or plasma Model/Catalog Number: EIA-1292
FDA Enforcement
Class III
·Ongoing·DRG International, Inc.·November 6, 2024