Section 4 - Product Stability & On-Going Testing Using Table 5 below, please specify the current shelf-life of the product: If additional Tables are required, please copy and paste this format underneath Table 5 Table 5 Stability claims Product name Model Numbers Shelf life Time Period and storage conditions (where applicable, if not please state N/A) Claimed Shelf life In use stability On board stability Re-constitution Open vial/bottle Shipping/Transport Stability Duration of transport Expected temperatures Humidity Has the product shelf life / expiry date changed during the current product certification cycle? Yes No If yes, please explain: Is the stated shelf life based on accelerated or real time aging Yes No Please provide an update on any real time aging activities currently underway, or completed during the current product certification cycle: N/A Yes No Is regular monitoring of the stability of an IVD reagent already on the market completed? Yes No If Yes, please explain and provide data:
Section 4 - Product Stability & On-Going Testing Using Table 5 below, please specify the current shelf-life of the product: If additional Tables are required, please copy and paste this format underneath Table 5 Table 5 Stability claims Product name Model Numbers Shelf life Time Period and storage conditions (where applicable, if not please state N/A) Claimed Shelf life In use stability On board stability Re-constitution Open vial/bottle Shipping/Transport Stability Duration of transport Expected temperatures Humidity Has the product shelf life / expiry date changed during the current product certification cycle? Yes No If yes, please explain: Is the stated shelf life based on accelerated or real time aging Yes No Please provide an update on any real time aging activities currently underway, or completed during the current product certification cycle: N/A Yes No Is regular monitoring of the stability of an IVD reagent already on the market completed? Yes No If Yes, please explain and provide data:
GRF-25-32.docx