9 results
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79ms
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Sources: EU EUDAMED, US FDA
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3PLUS1 Multilevel Plasma Calibrator Set, Order No. 75128 - Product Usage: The kit is intended for amino acid metabolic screening, confirmation of a tentative diagnosis, and monitoring of treatment in individuals diagnosed with a metabolic disorder.
FDA Enforcement
Class II
·Terminated·Chromsystems Instruments & Chemicals GmbH·December 16, 2020
6PLUS1 Multilevel Saliva Calibrator Set Cortisol Cortisone in Saliva, Order No. 73039 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.
FDA Enforcement
Class II
·Completed·Chromsystems Instruments & Chemicals GmbH·December 9, 2020
MassChrom Cortisol, Cortisone Saliva Control Level II, Order No. 0350 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.
FDA Enforcement
Class II
·Completed·Chromsystems Instruments & Chemicals GmbH·December 9, 2020
MassChrom Amino Acid Analysis Plasma Control Level I, Order No. 0471 - Product Usage: The kit is intended for amino acid metabolic screening, confirmation of a tentative diagnosis, and monitoring of treatment in individuals diagnosed with a metabolic disorder.
FDA Enforcement
Class II
·Terminated·Chromsystems Instruments & Chemicals GmbH·December 16, 2020
MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I
FDA Enforcement
Class II
·Terminated·Chromsystems Instruments & Chemicals GmbH·July 13, 2022
MassChrom Amino Acid Analysis Plasma Control Level II, Order No. 0472 - Product Usage: The kit is intended for amino acid metabolic screening, confirmation of a tentative diagnosis, and monitoring of treatment in individuals diagnosed with a metabolic disorder.
FDA Enforcement
Class II
·Terminated·Chromsystems Instruments & Chemicals GmbH·December 16, 2020
MassChrom Cortisol, Cortisone Saliva Control Level I, Order No. 0349 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.
FDA Enforcement
Class II
·Completed·Chromsystems Instruments & Chemicals GmbH·December 9, 2020
MassChrom Amino Acid Analysis Plasma Control Level III, Order No. 0473 - Product Usage: The kit is intended for amino acid metabolic screening, confirmation of a tentative diagnosis, and monitoring of treatment in individuals diagnosed with a metabolic disorder.
FDA Enforcement
Class II
·Terminated·Chromsystems Instruments & Chemicals GmbH·December 16, 2020
MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level II
FDA Enforcement
Class II
·Terminated·Chromsystems Instruments & Chemicals GmbH·July 13, 2022