Product Update: Specimen Type Change and Shelf-Life Extension for Celltrion DiaTrust™ COVID-19 Ag Rapid Test
On May 16, 2022, the specimen type for the intended use was changed to mid-turbinate nasal swabs only. The intended use excludes the claim for nasopharyngeal swabs to reduce the associated risks if the prescription use Celltrion DiaTrust™ COVID-19 Ag Rapid Test were distributed to patients, as they are an invasive specimen type and not suitable for patient use.
On March 2, 2023, FDA also granted Celltrion a shelf-life extension from 18 months to 24 months for the Celltrion Diatrust™ COVID-19 Ag Rapid Tests when unopened and stored accordingly to labeled packaging and handling instructions. Please refer to the new expiration date, applicable to all components inside, on the outer box of each product.