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YY/T 1673-2019: Amphetamine detection kit(colloidal gold method)
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Std ID	Version	USD	Buy	Deliver [PDF] in	Title (Description)
YY/T 1673-2019	English	119	Add to Cart	3 days [Need to translate]	Amphetamine detection kit(colloidal gold method)

YY/T 1673-2019: Amphetamine detection kit(colloidal gold method)

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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. ...