Simplexa™ Molecular Assays
The Simplexa™ molecular chemistries are reliable and clinically validated products designed for qualitative and multi-analyte detection. These real-time PCR assays are designed to run on the 3M™ Integrated Cycler using either the Universal Disc (96 wells) or Direct Amplification Disc (8 wells).
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Simplexa™ Adenovirus Molecular Control
MOL8011Focus Diagnostics’ Simplexa™ Adenovirus Molecular Control consists of inactivated adenovirus intended to be used as a control in molecular testing. This control is not intended for use with donor screening tests.
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Simplexa™ BKV Kit
MOL2300A real-time PCR assay intended for the in vitro quantitative detection of BK Virus.
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Simplexa™ BKV Molecular Control
MOL8009Focus Diagnostics’ Simplexa™ BKV Molecular Control consists of a DNA fragment to a well conserved region of BKV VP2 gene intended to be used as a control in molecular testing. This control is not intended for use as a control with screening tests for the presence of BKV in blood or blood products.
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Simplexa™ BKV Quantitation Standards
MOL2310Simplexa™ BKV Quantitation Standards are intended to establish a standard curve with the Simplexa™ BKV assay on the 3M™ Integrated Cycler.
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Simplexa™ Bordetella Molecular Control
MOL8006Focus Diagnostics’ Simplexa™ Bordetella Molecular Control consists of a 625 bp DNA fragment containing both the IS481 and IS1001 target regions intended to be used as an unassayed control in molecular testing. This control is not intended for use with donor screening tests.
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Simplexa™ Bordetella Universal Direct Kit
MOL2700A real-time PCR assay for the in vitro qualitative direct detection and discrimination of Bordetella pertussis and/or Bordetella parapertussis DNA. Extraction and amplification is performed in one protocol with no separate nucleic acid extraction step. This kit contains sufficient reagents to perform 100 reactions directly from the specimen.
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Simplexa™ Bordetella Universal Direct Kit
MOL2775A real-time PCR assay for the in vitro qualitative direct detection and discrimination of Bordetella pertussis and/or Bordetella parapertussis DNA. Extraction and amplification is performed in one protocol with no separate nucleic acid extraction step. This higher volume version of the MOL2700 kit contains sufficient reagents to perform 1000 reactions directly from the specimen.
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Simplexa™ C. difficile Universal Direct Kit
MOL2975A real-time PCR assay for the in vitro qualitative direct detection of the toxin B gene (tcdB) of C. difficile. Extraction and amplification is performed in one protocol with no separate nucleic acid extraction step.
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Simplexa™ CMV Kit
MOL2200A real-time PCR assay intended for the in vitro quantitative detection of cytomegalovirus (CMV).
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Simplexa™ CMV Molecular Control
MOL8002Focus Diagnostics’ Simplexa™ CMV Molecular Control consists of a DNA fragment containing a well conserved region of CMV UL83 gene intended to be used as a control in molecular testing. This control is not intended for use as a control with screening tests for the presence of CMV in blood or blood products.
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