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™ 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™ Influenza A H1N1 (2009) Kit
MOL2500A real-time RT-PCR assay intended for the in vitro qualitative detection and differentiation of seasonal influenza A and 2009 H1N1 influenza viral RNA.
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Simplexa™ Flu A/B & RSV Kit
MOL2600A real-time RT-PCR assay intended for the in vitro qualitative detection and discrimination of influenza A, influenza B and respiratory syncytial virus (RSV).
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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 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™ 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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Simplexa™ Dengue Molecular Control
MOL3103CFocus Diagnostics' Simplexa™ Dengue Molecular Control consists of inactivated Dengue virus 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™ EBV Molecular Control
MOL8008Focus Diagnostics’ Simplexa™ EBV Molecular Control consists of a DNA fragment to a well conserved region of EBV LMP2A 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 EBV in blood or blood products.
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Simplexa™ Extraction and Amplification Control Set
MOL9000This set consists of a DNA template and labeled primer pair intended to be used as a process control to detect systemic variation that may arise during the extraction and amplification steps of real-time polymerase chain reaction (PCR) assays. The set is not intended to monitor other real-time PCR processes.
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Simplexa™ Extraction and Amplification Control Set - RNA
MOL9200This set consists of a DNA template and labeled primer pair intended to be used as a process control to detect systemic variation that may arise during the extraction and amplification steps of real-time polymerase chain reaction (PCR) assays. The set is not intended to monitor other real-time PCR processes.
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