Dear valued customer, you may have found an orange sticker on your product.

 

We herewith confirm the extension of the shelf life for our product 4401001: InTec Rapis SARS-CoV-2 Antibody (IgM/IgG) duo test; 25 pieces.

This applies to batches GJ20030284 and GJ20030288.

The originally stated shelf life until September 2020 has been extended to March 2021.

 

The original, 6 month shelf life claimed in the IFU was based on a 1-month accelerated stability study. According to the subsequent 2-month accelerated stability study, shelf life was extended to 12 months.

The full stability study report can be found via this link: Declaration shelf life from InTec

 

The identical information can be found on InTec webpage: www.intecasi.com/news/157-shelf-life-of-rapid-sars-cov-2-antibody-test-is-extended-to-12-months