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FDA Home Page | Contact eHCTERS Technical Support HUMAN CELL AND TISSUE ESTABLISHMENT REGISTRATION Public Query Establishment Details Establishment Name and Location Current Status: Last Annual Registration
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01
Obtain the necessary supplies such as cell culture media, pipettes, and cell culture dishes.
02
Thaw the frozen cells according to the manufacturer's instructions.
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Prepare the cell culture media by adding the appropriate supplements and antibiotics.
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Plate the cells in the cell culture dish and incubate them at the optimal temperature and CO2 levels.
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Change the media regularly to provide the cells with nutrients and remove waste products.
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Monitor the cells for growth and confluency, and passage them as needed to prevent overcrowding.

Who needs human cell and tissue?

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Researchers studying cell biology and tissue engineering
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Pharmaceutical companies testing drugs and treatments
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Human cells and tissues refer to the biological components that make up human anatomy, which can be used for medical and research purposes, including transplantation and regenerative medicine.
Entities that handle, process, or distribute human cells and tissues, such as tissue banks, hospitals, and laboratories, are typically required to file reports regarding human cell and tissue.
To fill out human cell and tissue reports, entities must gather necessary data, complete the required forms accurately, and submit them to the appropriate regulatory authority, following the guidelines provided.
The purpose of human cell and tissue is to facilitate medical treatments, enable research, enhance knowledge of human biology, and improve patient care through transplantation and therapy.
Reportable information typically includes donor information, processing details, safety protocols, and any adverse events or outcomes related to the use of human cells and tissues.
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