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CareStart COVID-19 Home Test Kit Update

Please be informed, the shelf-life expiration date of the Access Bio, Inc. CareStart COVID-19 Antigen Home Test (EUA210314) has been extended. As part of the EUA requirement, the US Food and Drug Administration (FDA) requested Access Bio, Inc. to indicate shelf life of the product based on the real-time stability data.

To comply with the requirement, Access Bio, Inc. submitted the real-time stability data on December 1st, 2021, and the FDA granted nine (9) months of shelf-life at 1-30 degrees celsius for the CareStart COVID-19 Antigen Home Tests as of January 20th, 2022.

Please refer to the attached list of lot numbers labeled with a six (6) month shelf-life. These products' shelf-life will now be extended to nine (9) months.