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Sources: EU EUDAMED, US FDA
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Multiphor II Electrophoresis System GE HealthCare Product Number: 18-1018-06 PerkinElmer Part Number: 2117-004 Product Usage: Multiphor II Electrophoresis System is a versatile modular electrophoresis system for horizontal electrophoresis, isoelectric focusing, 2-D electrophoresis and electrophoretic transfer Note: The Multiphor II Electrophoresis System (Class I) is the platform used with the hemoglobin electrophoresis gel kit ( Class II) sold by PerkinElmer as the Resolve Hemoglobin Kit (K050709: Product code JJN). The RESOLVE Systems Hemoglobin kit (K050709) is designed to separate whole blood, cord blood or dried blood spot specimen for detection of normal and variant hemoglobins by isoelectric focusing.
FDA Enforcement
Class II
·Terminated·Perkinelmer Life Sciences, Inc.·July 12, 2017
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015