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Free triiodothyronine (FT3)testing kit
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Basic data
| Standard ID | YY/T 1724-2020 (YY/T1724-2020) |
| Description (Translated English) | Free triiodothyronine (FT3)testing kit |
| Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) |
| Classification of Chinese Standard | C44 |
| Classification of International Standard | 11.100 |
| Word Count Estimation | 10,152 |
| Date of Issue | 2020-06-30 |
| Date of Implementation | 2021-06-01 |
| Issuing agency(ies) | State Drug Administration |
YY/T 1724-2020: Free triiodothyronine (FT3)testing kit
---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.
Free triiodothyronine (FT3)testing kit
ICS 11.100
C44
People's Republic of China Pharmaceutical Industry Standard
Free Triiodothyronine Determination Kit
2020-06-30 released
2021-06-01 implementation
Issued by the State Drug Administration
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that certain contents of this document may involve patents. Publication of this document
The agency is not responsible for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is under the jurisdiction of the National Medical Clinical Laboratory and In Vitro Diagnostic System Standardization Technical Committee (SAC/TC136).
Drafting organizations of this standard. Beijing Institute of Medical Device Inspection, Suzhou Xinbo Biotechnology Co., Ltd., Siemens Medical Diagnostic Products (Shanghai) Co., Ltd.
The main drafters of this standard. Wang Ruixia, Tu Xianju, Sun Jingjing.
Free Triiodothyronine Determination Kit
1 Scope
This standard specifies the classification, requirements, test methods, and test methods of the free triiodothyronine determination kit (hereinafter referred to as FT3 kit)
Labeling and instructions for use, packaging, transportation and storage.
This standard applies to methods such as enzyme labeling, (electro) chemiluminescence labeling, (time-resolved) fluorescent labeling, etc., using the competition method as the principle in vitro
An immunoassay kit for the quantitative determination of free triiodothyronine (FT3).
This standard does not apply to.
a) Reagents for the qualitative or semi-quantitative determination of human free triiodothyronine (such as test strips, biochips, etc.) labeled with colloidal gold or other methods;
b) All kinds of radioimmunoassay or immunoradioassay kits labeled with radioisotopes such as 125I;
c) The free thyroid hormone calibrator and free thyroid quality control product that are to be sold separately, or the calibrator and quality control product in the FT3 kit.
2 Normative references
The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article
Pieces. For undated references, the latest version (including all amendments) applies to this document.
GB/T 21415-2008 Metrological traceability of measurement of calibrators and control substance assignments in biological samples of in vitro diagnostic medical devices
GB/T 29791.2 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 2.In vitro diagnostic tests for professional use
3 categories
FT3 kits can be divided into enzyme labeling, (electro) chemiluminescence labeling, (time-resolved) fluorescent labeling, etc. according to different labeling methods;
The solid phase carrier can be divided into microplate type, tube type, magnetic particles, microsphere beads and plastic beads, etc.; it can be divided into manual operation according to different operation processes.
Practice and automatic operation of the instrument.
4 requirements
4.1 Appearance
The appearance should meet the following requirements.
a) Each component of the reagent (kit) should be complete and complete, and no liquid leakage;
b) The logo should be clear and easy to identify.
4.2 Traceability
The manufacturer should provide the source, value assignment process and uncertainty of the calibrator used in accordance with GB/T 21415-2008 and related regulations.
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