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Title: CareStartTM COVID-19 ANTIGEN HOME TEST and on/go COVID-19 ANTIGEN SELF-TEST SHELF-LIFE EXTENSION CONFIRMATION Date: Feb 1st, 2023
To Whom It May Concern, This letter is to inform you regarding the extension of the shelf-life expiration date of the Access Bio, Inc. CareStartTM COVID-19 Antigen Home Test (EUA210314) and the authorized distributor Intrivo’s on/go COVID-19 Antigen Self-Test. As a part of the EUA requirement, the US Food and Drug Administration (FDA) requested Access Bio, Inc. to indicate the shelf-life of the product based on real-time stability data. To comply with the requirement, Access Bio, Inc. submitted the real-time stability data on January 26th, 2023, and the FDA granted twenty-one (21) months of shelf-life at 1–30°C for the CareStartTM COVID-19 Antigen Home Test and on/go COVID-19 Antigen Self-Test as of Feb 1st, 2023. Attachment A lists the lot numbers of on/go COVID-19 Antigen Self-Test products labeled with six (6) or nine (9) months of shelf-life. These products’ shelf-life will extend to twenty-one (21) months.
Name: Seungjae Baek Job Title: Senior Managing Director Customer Service
Signature: