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- Updated ResistancePlus® MG IFU documents (November 2023)
- UPDATE: addition of UKCA mark and notified number, change of European authorised representative, updated manufacturing address, correction of storage temperature (to -25°C to -15°C), addition of sample collection devices and positive control material in Section 7, addition of a summary of instructions for each validated specimen in Section 10, update to glossary.
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- Updated ResistancePlus® GC IFU documents (November 2023)
- UPDATE: addition of UKCA mark and notified number, change of European authorised representative, updated manufacturing address, correction of storage temperature (to -25°C to -15°C), addition of sample collection devices and positive control material in Section 7, addition of a summary of instructions for each validated specimen in Section 10, update to glossary.
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- Updated PlexPCR® HSV-1&2, VZV IFU documents (November 2023)
- UPDATE: addition of UKCA mark and notified number, change of European authorised representative, updated manufacturing address, correction of storage temperature (to -25°C to -15°C), addition of sample collection devices and positive control material in Section 7, addition of a summary of instructions for each validated specimen in Section 10, update to glossary.
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- Updated PlexPCR® VHS IFU documents (November 2023)
- UPDATE: addition of UKCA mark and notified number, change of European authorised representative, updated manufacturing address, correction of storage temperature (to -25°C to -15°C), addition of sample collection devices and positive control material in Section 7, addition of a summary of instructions for each validated specimen in Section 10, update to glossary.
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- Updated PlexPCR® RespiVirus IFU documents (November 2023)
- UPDATE: addition of UKCA mark and notified number, change of European authorised representative, updated manufacturing address, correction of storage temperature (to -25°C to -15°C), addition of sample collection devices and positive control material in Section 7, addition of a summary of instructions for each validated specimen in Section 10, update to glossary.
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- Updated PlexPCR® SARS-CoV-2 IFU documents (November 2023)
- UPDATE: addition of UKCA mark and notified number, change of European authorised representative, updated manufacturing address, correction of storage temperature (to -25°C to -15°C), addition of sample collection devices and positive control material in Section 7, addition of a summary of instructions for each validated specimen in Section 10, update to glossary.
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- Updated PlexPCR® Colour Compensation IFU documents (May 2022)
- UPDATE: correction of storage temperature (to -25°C to -15°C), and removal of the LC480 I instrument.
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- Updated PlexPCR® SARS-CoV-2 IFU documents (March 2022)
- UPDATE: update of the FastFinder software to include a flag notification for samples with a high viral load, correction of storage temperature (to -25°C to -15°C), and instructions for the use of the CFX on board software for result analysis.
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- Updated PlexPCR® SARS-CoV-2 IFU documents (February 2022)
- UPDATE: addition of the MGISP-960 extraction instrument and instructions for the use of the LC-480 II on board software for result analysis.
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- Updated ResistancePlus® GC IFU documents (November 2021)
- UPDATE: removal of PlexPCR® Amplification Control Kit from materials recommended but not provided, addition of workflow with new REFLEX software, addition of the cobas z480 as a validated qPCR instrument with associated instructions and software, addition of DSP Virus/Pathogen Mini Kit (QIAGEN, Cat no 937036) in Section 7: Materials required but not provided, amendment to the CFX96™ Dx instrument name, addition of QIAsymphony SP instrument, and addition of Warnings, Precautions and Limitations for Assay Plug-ins.
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- Updated ResistancePlus® MG IFU documents (October 2021)
- UPDATE: removal of PlexPCR® Amplification Control Kit from materials recommended but not provided, addition of workflow with new REFLEX software, addition of the cobas z480 as a validated qPCR instrument with associated instructions and software, addition of DSP Virus/Pathogen Mini Kit (QIAGEN, Cat no 937036) in Section 7: Materials required but not provided, amendment to the CFX96™ Dx instrument name, amendment to the figures referenced in Section 20.1, amendment to the template concentration names listed in Table 36 Operator Variability, recommended control material is now listed under Section 7 “Materials recommended but not provided”, and SpeeDx address updated to new facility
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- Updated PlexPrime® Alpha/Beta/Gamma+ PI document (October 2021)
- UPDATE: correction to the data analysis table providing clarification for cq cut-offs for an invalid result.
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- Updated PlexPCR® SARS-CoV-2 IFU documents (August 2021)
- UPDATE: specifically listed validated specimen types, description of the intended target population, removal of description related to sample storage, and amendments to the descriptions relation to sample collection, transport and storage.
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- Updated PlexPCR® SARS-CoV-2 IFU documents (July 2021)
- UPDATE: expanded the range of validated extraction platforms and qPCR instrument options
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- Updated PlexPCR® RespiVirus IFU documents (April 2021)
UPDATE: more clarification for the intended purpose of the Positive Controls
Find documents here - Updated ResistancePlus® GC IFU documents (April 2021)
UPDATE: more clarification for the intended purpose of the Positive Controls
Find documents here - Updated SpeeDx Company Brochure (October 2020)
UPDATE: Partnerships & Global Impact
Find document here - Updated ResistancePlus® MG Clinical Brochure (October 2020)
UPDATE: Cure rate graph 2018 figure updated
Find product document here - NEW SpeeDx Partner Event Go to video
- Updated ResistancePlus® MG IFU&PI documents (December 2019)
UPDATE: expanded the range of validated extraction platforms and qPCR instrument options
Find product documents here - Updated Customer Presentation – Diagnostics Defining Therapy (June 2019)
Find product documents here - Fast Facts product documents: easy-to-use documents summarising product features (April 2019)
Find product documents here - Updated product brochures with the refreshed branding – UPDATE: New branding (April 2019)
Find product documents here - NEW ResistancePlus® GC product documents – UPDATE: ResistancePlus® GC has received CE-IVD marking (December 2018)
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