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Nucleic acid amplification reverse dot blot reagent(kit)
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Basic data
| Standard ID | YY/T 1303-2015 (YY/T1303-2015) |
| Description (Translated English) | Nucleic acid amplification reverse dot blot reagent(kit) |
| Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) |
| Classification of Chinese Standard | C44 |
| Classification of International Standard | 11.100 |
| Word Count Estimation | 8,883 |
| Date of Issue | 2015-03-02 |
| Date of Implementation | 2016-01-01 |
| Quoted Standard | GB/T 191; YY/T 0466.1 |
| Regulation (derived from) | The State Food and Drug Administration Announcement 2015 No. 8 |
| Issuing agency(ies) | State Food and Drug Administration |
| Summary | This Standard specifies the reverse dot blot nucleic acid amplification reagent (kit) [hereinafter referred to as reagent (kit)] of terms and definitions, requirements and test methods, marking, labeling and instructions for use, packaging, transportation and storage requirements. This Standard applies to in vitro diagnostic reagents for nucleic acid amplification reverse dot blot (box). |
YY/T 1303-2015: Nucleic acid amplification reverse dot blot reagent(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.
Nucleic acid amplification reverse dot blot reagent (kit)
ICS 11.100
C44
People's Republic of China pharmaceutical industry standards
Reverse dot blot nucleic acid amplification reagent (box)
Issued on. 2015-03-02
2016-01-01 implementation
China Food and Drug Administration released
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
Please note that some of the content of this document may involve patents. Distribution of this document
Institutions do not assume the responsibility to identify these patents.
This standard was proposed by the China Food and Drug Administration.
This standard by the national medical clinical laboratory testing and in vitro diagnostic systems for Standardization Technical Committee (SAC/TC136) centralized.
This standard was drafted. Beijing Medical Device Testing, Zhongshan Da An Gene Co., ADB to biotechnology (Shenzhen)
Limited.
The main drafters of this standard. Wangrui Xia, Gao Xu, Ren dimension, He Xueying.
Reverse dot blot nucleic acid amplification reagent (box)
1 Scope
This standard specifies the reverse dot blot nucleic acid amplification reagent (box) [hereinafter referred to as reagent (box)] terms and definitions, requirements and test methods
Marking, labeling and instructions for use, packaging, transportation and storage requirements.
This standard applies to in vitro diagnostic reagents for nucleic acid amplification reverse dot blot (box).
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
GB/T 191 Packaging - Pictorial signs
Symbols - Part 1 YY/T 0466.1 medical equipment used with medical device labels, labeling and information. General requirements
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
Reverse dot blot reversedotblot; RDB
By a tagged nucleic acid sample with previously immobilized on a solid support specific probe hybridization, the nucleic acid sample is detected
No Technical containing the desired gene fragment.
4 Requirements and test methods
4.1 Appearance
The kit should specify appearance requirements. In natural light, visual inspection, the appearance should at least meet the following conditions.
a) reagent (box) component is complete;
b) packaging clean appearance, no leaks, no damage;
c) signs, labels legible.
4.2 The detection limit
The kit should be prescribed limit of detection, detection limits and clear determination requirements. Setting the detection limit of the reference product should follow the following principles.
a) shall prescribe and provide reagent (box) detection limit of the design range can detect all targets of gene fragments;
b) where applicable, the use of national reference for verification;
c) the target gene fragment kit can detect more categories (n≥3), select at least two as reference material to verify the detection limit;
d) the detection limit of the selected reference material should be representative.
4.3 Reference product meets the positive rate
Detection national reference and/or reference materials business, the positive reference material, each sample was measured 1, the test results were positive, in line with
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