HCT/P, no living cells
Biologic — Acellular
Acellular HCT/Ps under Part 1271. Section 361 or 351 turns on manipulation and use.
No patient needed
- 1What it is
- 2Who makes it
- 3Fit for your practice
- 4Products
- 5Build your order
What it is
Human cells, tissues and cellular and tissue-based products containing no living cells, regulated under 21 CFR Part 1271. Whether a given product is a section 361 HCT/P — needing no license — or a section 351 biologic needing an approved BLA turns on minimal manipulation and homologous use.
Patient named before it is madeNo