Primary Cell Products

Primary Cell Products, Total:15 items.

In the international standard classification, Primary Cell Products involves: Biology. Botany. Zoology, Medical sciences and health care facilities in general, Pharmaceutics.

Group Standards of the People's Republic of China, Primary Cell Products

• T/CSCB 0008-2021 Primary human hepatocyte
• T/SDHCST 001-2023 General Principles on the Non-Clinical Studies of the Cell Therapy Medical Products
• T/CMBA 021-2023 Specification of quality management for ancillary materials present during the production of cellular therapeutic products
• T/WEBIO 0001-2023 Specification of human primary cell preparation and quality control
• T/SDHCST 008-2023 Procedures for Immunogenicity and Immunotoxicity of the Cell Therapy Medical Products
• T/CIET 416-2024 Stem cell anti-aging product development guide
• T/CGCPU 011-2020 Quality Control Requirements for Immune Cell Products
• T/CGCPU 010-2020 Environmental requirements for the preparation of immune cell products

SCC, Primary Cell Products

• BS 1335:1946 Specification for air depolarized primary cells
• BS 1335:1968 Specification for air depolarized primary cells

US-FCR, Primary Cell Products

• FCR 21 CFR PART 1271-2014 HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS
• FCR 21 CFR PART 1271-2015 HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS
• FCR 21 CFR PART 1271-2012 HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS

American National Standards Institute （ANSI), Primary Cell Products

• ADA TR 1089-2019 Track and Trace for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

American Society for Testing and Materials (ASTM), Primary Cell Products

• ASTM F3368-19 Standard Guide for Cell Potency Assays for Cell Therapy and Tissue Engineered Products

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