Components, Parts catalogue Elisa, photometry, Tests (for and/or Accessories Code number chemiluminecence,…) reagents) as per product label File. No: LB-FO-08 Rev: 2 3 of 6 In addition to items 1 to 7, of the Device Registration Application following information is requested, please indicate (X) which of the relevant information requirements listed below are included as attachments to this application. For details regarding content and format please refer to the GUIDANCE FOR FOR AN IVD MEDICAL DEVICE “APPLICATION REGISTRATION Cover Page X Executive summary X Table of contents - Device Description (principles of operation & materials used in construction and X. Please refer to packaging, describing each of the functional components of the device, with labeled pictorial Instructions for representation of the device in the form of diagrams, photographs or drawings.) Use Design Philosophy X. Please refer to Instructions for Use Marketing History X
Components, Parts and/or Accessories as per product label Code catalogue number Elisa, photometry, chemiluminecence,…) Tests (for reagents) File. No: LB-FO-08 Rev: 2 3 of 6 In addition to items 1 to 7, of the Device Registration Application following information is requested, please indicate (X) which of the relevant information requirements listed below are included as attachments to this application. For details regarding content and format please refer to the GUIDANCE FOR “APPLICATION FOR AN IVD MEDICAL DEVICE REGISTRATION Cover Page X Executive summary X Table of contents - Device Description (principles of operation & materials used in construction and packaging, describing each of the functional components of the device, with labeled pictorial representation of the device in the form of diagrams, photographs or drawings.) X. Please refer to Instructions for Use Design Philosophy X. Please refer to Instructions for Use Marketing History X
Iran-Application-Form-Revision-2.docx