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YY/T 1673-2019: Amphetamine detection kit(colloidal gold method)
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1673-2019 | English | 119 |
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Amphetamine detection kit(colloidal gold method)
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YY/T 1673-2019
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Basic data | Standard ID | YY/T 1673-2019 (YY/T1673-2019) | | Description (Translated English) | Amphetamine detection kit(colloidal gold method) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100 | | Word Count Estimation | 6,630 | | Date of Issue | 2019 | | Date of Implementation | 2020-10-01 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the compound information, requirements, test methods, labels, instructions for use, packaging, transportation and storage of amphetamine detection kits (colloidal gold method) (hereinafter referred to as detection kits). This standard applies to the detection kit for qualitative detection of amphetamine (AMP) in human urine by the principle of colloidal gold immunochromatography and the combined detection kit containing amphetamine. This standard does not apply to test kits for non-human urine testing or test kits using other methods. | YY/T 1673-2019: Amphetamine detection kit(colloidal gold method)---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.
Amphetamine detection kit (colloidal gold method)
ICS 11.100
C44
People's Republic of China Pharmaceutical Industry Standard
Amphetamine test kit (colloidal gold method)
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.
The main drafters of this standard. Zuo Ning, Chen Hua, Nan Nan.
Amphetamine test kit (colloidal gold method)
1 Scope
This standard specifies the compound information, requirements, and test methods of amphetamine detection kits (colloidal gold method) (hereinafter referred to as detection kits).
Laws, labels and instructions for use, packaging, transportation and storage.
This standard applies to the qualitative detection of amphetamine (AMP) in human urine by the principle of colloidal gold immunochromatography.
Detection kit and combined detection kit containing amphetamine.
This standard does not apply to.
a) Test kit for non-human urine testing;
b) Test kits using other methods.
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 Packaging, storage and transportation icon
GB/T 29791.2-2013 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 2. In vitro diagnostics for professional use
Reagent
3 Compound Information
Amphetamine (CAS). 300-62-9, molecular formula. C9H13N, also known as amphetamine. Including its optical isomers and
Various types of salt.
4 Requirements
4.1 Physical properties
4.1.1 Appearance
The appearance should be flat, the material should be firmly attached, and the content should be complete. The inner packaging should be clean, free of leaks and not damaged.
4.1.2 Film strip width
The width of the film strip should not be less than 3mm.
4.1.3 Liquid migration speed
The liquid migration speed should not be less than 20mm/min.
4.2 Positive reference rate
Testing with national positive reference materials or standardized positive reference materials should be positive.
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