Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen (HLA) Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation: Guidance for Industry
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
July 31, 2015
April 21, 2021
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