3 results
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70ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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arkray SPOTCHEM II Glucose Reagent test strips, Item No. 77101, MEDTEST DX Catalog # 77424. For the in vitro quantitative determination of glucose in human plasma from whole blood samples.
FDA Enforcement
Class I
·Terminated·Arkray Factory USA, Inc.·January 27, 2016
arkray SPOTCHEM II Basic Panel - 1 Reagent test strips, Product # 11726, MEDTEST DX Catalog # 77484. Calcium, Blood Urea Nitrogen, Glucose, Albumin, Creatinine. For the in vitro quantitative determination of calcium, blood urea nitrogen (BUN), glucose, albumin, and creatinine.
FDA Enforcement
Class I
·Terminated·Arkray Factory USA, Inc.·January 27, 2016
AUTION HYBRID AU-4050
FDA Enforcement
Class II
·Terminated·Arkray Factory USA, Inc.·June 26, 2019