cellular immune cells

cellular immune cells, Total:40 items.

The international standard classification for "cellular immune cells" includes: Medical materials .

The Chinese standard classification for "cellular immune cells" includes: Medical apparatus and devices in general .

未注明发布机构

CLSI H42-A2-2007 Flow cytometric enumeration of immune-defined cell populations

Group Standards of the People's Republic of China

T/GDMDMA 0001-2022 Interleukin 6 Detection kit (Chemiluminescent Immunoassay)
T/ZSA 146-2023 Technical requirements for Flow Cytometry validation of CD3、CD4、CD8 of immune cell product
T/ZSA 150-2023 Management requirements for donor materials of immune cell product
T/CGCPU 028-2023 Requirements for quality control on non gene modified immune cells clinical research
T/CI 390-2024 The technical regulation for preparation and clinical application of immuno-cell CIK from healthy person
T/CEAC 069-2024 Cell therapy Leukopak raw material collection and immune cell separation technical requirements
T/CEAC 044-2024 Safety management specifications for the separation, preparation and storage of immune cells
T/CGCPU 009-2020 Control requirements for the preparation process of immune cell products
T/CGCPU 010-2020 Environmental requirements for the preparation of immune cell products
T/LNSI 004-2024 Human cytokine induced killer cell
T/CGCPU 018-2022 Technical requirements for CD3, CD4, CD8 flow cytometric detection and verification of immune cell products
T/SDHCST 008-2023 Procedures for Immunogenicity and Immunotoxicity of the Cell Therapy Medical Products
T/CGCPU 019-2022 Material management requirements for immune cell product donors
T/FDSA 0055-2024 Guidelines for the development of Cell immunotherapy products based on mRNA-LNP technology
T/CGCPU 011-2020 Quality Control Requirements for Immune Cell Products
T/LNSI 004-2023 Human cytokine induced killer cell
T/WJWCHCA 003-2024 Autologous Immune Cell Storage Service Organization's Quality and Credit Evaluation Standards
T/CGCPU 027-2023 Design specifications for clinical research protocol of immunotherapy
T/XSMIA 0004-2022 Quality Accreditation of Immunocyte Preparation Center

Professional Standard - Agriculture

298药典三部-2015 Biological activity-potency assay 3516 Anti-human T cell immunoglobulin potency assay (lymphocytotoxicity test) General 129
1259药典化学药和生物制品卷-2010 Chapter 17 Immunomodulatory Drugs 1. Immunosuppressive Drugs against Human T Cell Immunoglobulin
124药典三部-2020 Monograph Ⅱ Therapeutic anti-human T cell porcine immunoglobulin
125药典三部-2020 Monograph Ⅱ Therapeutic Anti-human T-cell Rabbit Immunoglobulins
77兽药产品说明书范本第三册-2013 Instructions for live vaccine swine fever live vaccine (cell source)
92药典三部-2010 Chapter Ⅱ Therapeutic Anti-human T-cell Rabbit Immunoglobulin
327药典三部-2020 Biological activity-potency assay 3516 Anti-human T cell immunoglobulin potency assay (lymphocytotoxicity test)
279药典四部-2015 3500 Biological activity-potency assay 3516 Anti-human T cell immunoglobulin potency assay (lymphocytotoxicity test)
1258药典化学药和生物制品卷-2010 Chapter 17 Immunomodulatory Drugs 1. Immunosuppressive Drugs Anti-Human T Cell CD3 Mouse Monoclonal Antibody
114药典三部-2015 Monograph Ⅱ Therapeutic Anti-human T-cell Rabbit Immunoglobulins
274药典四部-2020 3500 Biological activity-potency assay 3516 Anti-human T cell immunoglobulin potency assay (lymphocytotoxicity test)
113药典三部-2015 Monograph Ⅱ Therapeutic anti-human T cell porcine immunoglobulin
259药典三部-2010 Appendix Ⅹ XR Anti-human T cell immunoglobulin titer assay (lymphocytotoxicity test)
91药典三部-2010 Chapter Ⅱ Therapeutic anti-human T cell porcine immunoglobulin

Hebei Provincial Standard of the People's Republic of China

DB13/T 5332-2021 Technical specification for clinical operation of cellular immunotherapy

国家药监局

YY/T 1465.6-2019 Immunogenic evaluation method of medical devices―Part 6:Determination of animal spleen lymphocyte subsets by flow cytometry

国家食品药品监督管理局

YY/T 1465.4-2017 Immunogenic evaluation method of medical devices-Part4:Phagocytosis of mouse peritoneal macrophages on chicken erythrocytes- Ex-vivo method

American Society for Testing and Materials (ASTM)

ASTM F1906-98(2003) Standard Practice for Evaluation of Immune Responses In Biocompatibility Testing Using ELISA Tests, Lymphocyte, Proliferation, and Cell Migration

Korean Agency for Technology and Standards (KATS)

KS M ISO 4590-2018 Rigid cellular plastics — Determination of the volume percentage of open cells and of closed cells
KS M ISO 4590:2018 Rigid cellular plastics — Determination of the volume percentage of open cells and of closed cells

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