3 results
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52ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHBC100 - Product Usage: The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. The device is intended for Professional use only.
FDA Enforcement
Class II
·Ongoing·Axis-Shield Diagnostics, Ltd.·January 1, 2020
Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR100 - Product Usage: The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. The device is intended for Professional use only.
FDA Enforcement
Class II
·Ongoing·Axis-Shield Diagnostics, Ltd.·January 1, 2020
Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR1000 - Product Usage: The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. The device is intended for Professional use only.
FDA Enforcement
Class II
·Ongoing·Axis-Shield Diagnostics, Ltd.·January 1, 2020