1,306 results
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42ms
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Sources: EU EUDAMED, US FDA
MAS Urinalysis Control Level 1, Multi-analyte control (Assayed and Unassayed), Catalog/Part Numbers: 024222; Product is manufactured and distributed by Microgenics Corporation, a subsidiary of Thermo Fisher Scientific, Clinical Diagnostic Division, Fremont, CA MAS Urinalysis is intended for use in the clinical laboratory as a control for qualitative and semi-quantitative procedures used in routine urinalysis testing. Assay values are provided for specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and equipment. The product is suitable for use as a control material for physiochemical, chemical, and microscopic methods of routine urinalysis. Urinalysis may be used in conjunction with commercially available standardized systems for urine microscopic analysis.
FDA Recall
Terminated
·Thermofisher Scientive·Product code JJW·October 29, 2013
MAS Urinalysis Control Level 1, Multi-analyte control (Assayed and Unassayed), Catalog/Part Numbers: 024222; Product is manufactured and distributed by Microgenics Corporation, a subsidiary of Thermo Fisher Scientific, Clinical Diagnostic Division, Fremont, CA MAS Urinalysis is intended for use in the clinical laboratory as a control for qualitative and semi-quantitative procedures used in routine urinalysis testing. Assay values are provided for specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and equipment. The product is suitable for use as a control material for physiochemical, chemical, and microscopic methods of routine urinalysis. Urinalysis may be used in conjunction with commercially available standardized systems for urine microscopic analysis.
FDA Enforcement
Class III
·Terminated·Thermofisher Scientive·December 4, 2013
Thermo Fisher Scientific Oy
Manufacturer
🇫🇮 Finland·271 Basic UDI-DIs·345 Devices
Thermo Fisher Scientific Oy
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🇫🇮 Finland·TÜV Rheinland LGA Products GmbH
Thermo Fisher Scientific (Asheville) LLC
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Thermo Finnigan LLC.
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Life Technologies Corporation / Thermo Fisher Scientific
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Microgenics Corporation
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🇺🇸 United States·5 Basic UDI-DIs·5 Devices·1 Importer·TÜV Rheinland LGA Products GmbH
THERMO FISHER SCIENTIFIC OY
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THERMO FISHER SCIENTIFIC OY·5 products·🇫🇮 Finland
Thermo Fisher Scientific (Monterrey)
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THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC
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Thermo Fisher Scientific Baltics UAB
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Thermo Fisher Scientific Baltics UAB·5 products·🇱🇹 Lithuania
THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC
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THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC·2 products·🇺🇸 United States
Thermo Fisher Scientific (Suzhou) Instruments Co., Ltd
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Thermo Fisher Scientific (Suzhou) Instruments Co., Ltd·1 product·🇨🇳 China
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