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Recommendations for Obtaining a Labeling Claim for Communicable Disease Donor Screening Tests Using Cadaveric Blood Specimens from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)


Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, ,

Document Type:
Guidance for Industry
The purpose of this guidance document is to inform all establishments or persons engaged in the testing of donations of human tissue intended for transplantation and regulated under 21 CFR Part 1270 of the availability of two licensed donor screening tests labeled for use with cadaveric (post-mortem) blood specimens

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