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PG Ⅰ/Ⅱ testing kit
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Basic data
| Standard ID | YY/T 1672-2019 (YY/T1672-2019) |
| Description (Translated English) | PG ��/�� testing kit |
| Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) |
| Classification of Chinese Standard | C44 |
| Classification of International Standard | 11.100 |
| Word Count Estimation | 7,721 |
| Date of Issue | 2019 |
| Date of Implementation | 2020-10-01 |
| Issuing agency(ies) | State Drug Administration |
| Summary | This standard specifies the classification, requirements, test methods, labels and instructions for use, packaging, transportation and storage of pepsinogen I/II assay kits. This standard applies to pepsinogen I and pepsinogen II assay kits (hereinafter referred to as PGI/II kits). Including enzyme labeling, chemiluminescence labeling and other labeling methods immunoassay kits. This standard does not apply to semi-quantitative PGI/II reagents (such as test strips, etc.) labeled with colloidal gold or other methods, and various radioimmunization or immunoradiation kits labeled with radioisotopes such as 125I. |
YY/T 1672-2019: PG Ⅰ/Ⅱ 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.
PG Ⅰ/Ⅱ testing kit
ICS 11.100
C44
People's Republic of China Pharmaceutical Industry Standard
Pepsinogen Ⅰ/Ⅱ Assay Kit
Published on October 23,.2019
2020-10-01 implementation
Published 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 some elements 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 the Standardization Technical Committee for In vitro Diagnostic Systems (SAC/TC136).
This standard was drafted. China Food and Drug Inspection Institute, Shenzhen New Industry Biomedical Engineering Co., Ltd., Abbott Trade
(Shanghai) Co., Ltd., Beijing Yonghan Starport Biotechnology Co., Ltd.
The main drafters of this standard. Sun Nan, Qu Shoufang, Yu Ting, Huang Jie, Yuan Jinyun, Wu Xiaojun, Yin Xing.
Pepsinogen Ⅰ/Ⅱ Assay Kit
1 Scope
This standard specifies the classification, requirements, test methods, labels and instruction manuals, packaging, and transportation of pepsinogen Ⅰ/Ⅱ assay kits.
And storage.
This standard applies to the determination of pepsinogen Ⅰ and pepsinogen Ⅱ kits (hereinafter referred to as PG Ⅰ/Ⅱ kits). include
Immunoassay kit with labeling methods such as enzyme labeling and chemiluminescent labeling.
This standard does not apply to semi-quantitative determination of PG Ⅰ/Ⅱ reagents (such as test strips, etc.) with colloidal gold labels or other methods;
All kinds of radioimmunity or immunoradiation kits labeled with radioisotopes.
2 Normative references
The following documents are essential for the application of this document. For dated references, only the dated version applies to this article
Pieces. For undated references, the latest version (including all amendments) applies to this document.
GB/T 191-2008 Packaging, storage and transportation icon
GB/T 29791.2 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 2. In vitro diagnostic reagents for professional use
3 categories
According to the different labeling methods, it can be divided into enzyme labels, (electro) chemiluminescence labels, (time-resolved) fluorescent labels, etc.
It can be divided into microwell plate type, tube type, magnetic particles, microsphere beads and plastic beads, etc .; it can be divided into manual operation methods and instruments according to different operating processes.
Automatic method.
4 Requirements
4.1 Appearance
Manufacturers should specify appropriate appearance requirements based on the packaging characteristics of their products. Generally should have the composition and properties of each component of the kit; inside and outside
Requirements for clear packaging and labels.
4.2 Detection limit
4.2.1 The detection limit of PGⅠ should not be higher than 2.5ng/mL;
4.2.2 The detection limit of PGⅡ should not be higher than 1.4ng/mL.
4.3 Linear
Within the linear range given by the manufacturer (the lower limit of PGⅠ is not higher than 3ng/mL, the upper limit is not lower than.200ng/mL; the lower limit of PGⅡ is not high
At 1.5ng/mL, the upper limit is not less than 100ng/mL), the correlation coefficient (r) should not be less than 0.9900.
4.4 Accuracy
Accuracy should meet one of the following requirements.
...
