YY/T 1820-2021 English PDFUS$139.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 1820-2021: Specific antinuclear antibody IgG detecting kit (immunoblotting) Status: Valid
Basic dataStandard ID: YY/T 1820-2021 (YY/T1820-2021)Description (Translated English): Specific antinuclear antibody IgG detecting kit (immunoblotting) Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C44 Word Count Estimation: 7,769 Issuing agency(ies): State Drug Administration YY/T 1820-2021: Specific antinuclear antibody IgG detecting kit (immunoblotting)---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.Specific antinuclear antibody IgG detecting kit (immunoblotting) ICS 11:100:10 CCSC44 People's Republic of China Pharmaceutical Industry Standard Specific antinuclear antibody IgG detection kit (Western blotting) Published on 2021-12-06 2023-05-01 Implementation Released by the State Drug Administration forewordThis document is in accordance with the provisions of GB/T 1:1-2020 "Guidelines for Standardization Work Part 1: Structure and Drafting Rules of Standardization Documents" drafted: Please note that some content of this document may be patented: The issuing agency of this document assumes no responsibility for identifying patents: This document is proposed by the State Drug Administration: This document is under the jurisdiction of the National Standardization Technical Committee for Medical Clinical Laboratory and In Vitro Diagnostic Systems (SAC/TC136): This document is drafted by: Beijing Medical Device Inspection Institute, Beijing You'an Hospital Affiliated to Capital Medical University, Beijing Medical Device Technology Evaluation Center, Oumen Medical Diagnostics (China) Co:, Ltd:, Hooman Diagnostics (Beijing) Co:, Ltd: The main drafters of this document: Liu Yanchun, Yan Huiping, Sun Rong, Zhang Liuyan, Sun Dongna: Specific antinuclear antibody IgG detection kit (Western blotting)1 ScopeThis document specifies the requirements and test methods of the specific antinuclear antibody IgG detection kit (immunoblotting method) (hereinafter referred to as the kit): law, labelling, labelling, instructions for use, packaging, transportation and storage: This document is suitable for the qualitative detection of nuclear and cytoplasmic specific target antigens in human serum or plasma based on western blotting: Anti-nuclear antibody specific autoantibody IgG kit, including manual operation method and instrument automatic operation method products: This document does not apply to detection kits for total antinuclear antibodies:2 Normative referencesThe contents of the following documents constitute essential provisions of this document through normative references in the text: Among them, dated citations documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to this document: GB/T 191 Graphical signs of packaging, storage and transportation GB/T 29791:2 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 2: In vitro diagnostic reagents for professional use3 Terms and DefinitionsThe following terms and definitions apply to this document: 3:1 specific antinuclear antibody Antinuclear antibody (ANA), as an important biological marker of autoimmune disease, is the most widely used in clinical application: The most basic group of autoantibodies: ANA is a general term for autoantibodies targeting various components of eukaryotic cells: ANA detection It is divided into the detection of ANA total antibodies and the detection of specific autoantibodies against the target antigen: Specific antinuclear antibodies are those directed against a specific target antigen antinuclear antibody-specific autoantibodies: 3:2 detection limit limitofdetection The measured value obtained by a given measurement procedure, for which, given the probability of misjudgment of the presence of a component in the claimed substance as α, the sound The misjudgment probability of the absence of this component is called β: Note 1: IUPAC (International Union of Pure and Applied Chemistry), also translated as International Theory (Chemistry) Science) and the Union of Applied Chemistry: It is recommended that the default values of α and β be equal to 0:05: Note 2: It is used to describe a test procedure with a specific confidence level can be reported as the existence of the lowest measured value, is also used to refer to the minimum detectable concentration: Note 3: It was also called "minimum detection limit", "minimum detection limit" and "detection limit": [Source: YY/T 1713-2020, 3:6, with modifications] 3:3 cutoff Used to identify a sample as a measure of the threshold for the presence or absence of a particular disease, condition, or measurand: ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 1820-2021_English be delivered?Answer: Upon your order, we will start to translate YY/T 1820-2021_English as soon as possible, and keep you informed of the progress. 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