9 results
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57ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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Sterling Diagnostics, Inc., Enzymatic Glucose for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
FDA Enforcement
Class III
·Terminated·Sterling Diagnostics, Inc.·January 4, 2017
Sterling Diagnostics, Inc., SGPT Colorimetric for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
FDA Enforcement
Class III
·Terminated·Sterling Diagnostics, Inc.·January 4, 2017
Sterling Diagnostics, Inc., Enzymatic Uric Acid (Uricase Trinder) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
FDA Enforcement
Class III
·Terminated·Sterling Diagnostics, Inc.·January 4, 2017
Sterling Diagnostics, Inc., HDL Cholesterol (PEF Method) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
FDA Enforcement
Class III
·Terminated·Sterling Diagnostics, Inc.·January 4, 2017
Sterling Diagnostics, Inc. Serum Iron/IBC (Colorimetric) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
FDA Enforcement
Class III
·Terminated·Sterling Diagnostics, Inc.·January 4, 2017
Sterling Diagnostics, Inc.Colorimetric SGOT for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
FDA Enforcement
Class III
·Terminated·Sterling Diagnostics, Inc.·January 4, 2017
Enzymatic Cholesterol (Trinder/COD-CEH) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
FDA Enforcement
Class III
·Terminated·Sterling Diagnostics, Inc.·January 4, 2017
Urea Nitrogen/Color BUN (Enzymatic Berthelot) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
FDA Enforcement
Class III
·Terminated·Sterling Diagnostics, Inc.·January 4, 2017
Creatinine/Endpoint [Modified Heinegard-Tiderstrom] for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
FDA Enforcement
Class III
·Terminated·Sterling Diagnostics, Inc.·January 4, 2017