4 results
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24ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT; 100 test format, 1000 test format, and 200 test format; and Private Label: (Distributed by BECKMAN COULTER, for professional use only, on the BECKMAN COULTER AU platforms (AU400, AU480, AU680 and AU5800)) Product Usage: For in-vitro quantitative determination of total homocysteine in human plasma or serum.
FDA Enforcement
Class II
·Terminated·Axis-Shield Diagnostics, Ltd.·July 8, 2015
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