Regulatory

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Safety Data Sheets (SDS)

• Step 2 Plates and Step 1 tubes - Safety Data Sheet (SDS)
• Mastermixes - Safety Data Sheet (SDS)
• Synthetic Positive Controls - Safety Data Sheet (SDS)​​
• Swab Elution Buffer - Safety Data Sheet (SDS)​

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Product Advisory Notices

• 04/06/2018 Respiratory Products update. Advisory notice. See document
• 20/02/2018 New Step 1 Tube Format Advisory notice for AU and NZ. See document
• 20/02/2018 New Step 1 Tube Format Advisory notice for Europe. See document 
• 19/02/2018 New SDS's with mention of CLP Regulation. See document
• 20/12/2017 Staphylococcus + VRE (8-well) IVD Marked. See document
• 20/12/2017 Staphylococcus typing (8-well) CE Marked. See document
• 11/10/2017 Change of Manufacturer Address. See document
• 25/09/2017 CRE (16-well) (REF 21098) IVD Marked. See document
• 13/09/2017 Instrument and Software Name Update. See document
• 17/08/2017 Software Version Update. See document 
• 27/07/2017 New Faecal Synthetic Positive Control. See document 
• 19/07/2017 Faecal Panel Updates. See document  
• 20/06/2017 Noro-1 Melt Range Update. See document
• 20/06/2017 RSV background update. See document
• 18/05/2017 H3 Melt Range Update. See document
• 18/04/2017 Important changes to Easy-Plex 96 system. See document
• 18/04/2017 IVD Status update for CSF products. See document
• 04/04/2017 Phasing out of Easy-plex 72 (RotorGene) Products. See document
• 01/03/2017 HSV-1 Melt Range Update. See document
• 23/01/2017 Termination of 'Respiratory Pathogen C (10-well)' for EP72. See document
• 10/01/2017 Prolonged shelf life for synthetic positive controls. See document
• 06/01/2017 Vaginitis and Vaginosis (8-well) panel released for IVD. See document
• 21/12/2016 Interim Format of Easy-plex 96 Products. See document
• 20/12/2016 Faecal Pathogen B Update from 1st Jan '17. See document
• 15/12/2016 Respiratory Pathogen Panels Update from 1st Jan '17. See document
• 28/11/2016 New version 9 of Respiratory viruses featuring separate EV assay has been released. See document.
• 24/11/2016 New version 4 of Faecal Pathogen M panel has been released. See document
• 24/11/2016 New version 5 of Faecal Pathogen A panel has been released. See document
• 21/11/2016 Positive control packaging and catalog number change. See document
• 16/11/2016 Termination of certain Easy-Plex 72 products. See document
• 16/11/2016 CE-marking of kits containing Chlamydia and CMV. See document
• 31/08/2016 Release of the new Easy-Plex Software. See document
• 23/08/2016 Parechovirus assay listed as IVD. See document
• 23/08/2016 Faecal bacteria and Parasites (8-well) (REF 25040) IVD marked. See document
• 14/07/2016  New Labelling and Instructions for use. See document

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Certificates

ISO 13485 Certificate

98/79/EC IVDD Certificate