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Vitamin B12 testing kit(labelling immunoassay)
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Basic data
| Standard ID | YY/T 1677-2019 (YY/T1677-2019) |
| Description (Translated English) | Vitamin B12 testing kit(labelling immunoassay) |
| Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) |
| Classification of Chinese Standard | C44 |
| Classification of International Standard | 11.100 |
| Word Count Estimation | 7,723 |
| Date of Issue | 2019 |
| Date of Implementation | 2020-10-01 |
| Issuing agency(ies) | State Drug Administration |
| Summary | This standard specifies the requirements, test methods, identification, labels, instructions for use, packaging, transportation and storage of human vitamin B12 quantitative labeling immunoassay kits. This standard applies to immunoassay kits for the quantitative detection of vitamin B12 in human serum or plasma in vitro. This standard does not apply to reagents (such as test strips, biochips, etc.) for the qualitative or semi-quantitative determination of human vitamin B12 labeled with colloidal gold or other methods; vitamin B12 calibrators and vitamin B12 quality controls intended to be sold separately Taste. |
YY/T 1677-2019: Vitamin B12 testing kit(labelling immunoassay)
---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.
Vitamin B12 testing kit (labelling immunoassay)
ICS 11.100
C44
People's Republic of China Pharmaceutical Industry Standard
Vitamin B12 Assay Kit (Labeled Immunoassay)
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. Beijing Medical Device Inspection Institute, Orsendo Medical Devices Trading (China) Co., Ltd.
The main drafters of this standard. Zou Yingshu and Shi Weihong.
Vitamin B12 Assay Kit (Labeled Immunoassay)
1 Scope
This standard specifies requirements for human vitamin B12 quantitative labeling immunoassay kits, test methods, identification, labels, instructions for use,
Packaging, transportation and storage.
This standard is applicable to immunoassay kits for the quantitative determination of vitamin B12 in human serum or plasma in vitro.
This standard does not apply to.
a) Qualitative or semi-quantitative reagents (such as test strips, biochips, etc.) for human vitamin B12 labeled with colloidal gold or other methods;
b) Vitamin B12 calibrators and vitamin B12 quality controls intended for sale separately.
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 21415 Metrological tracing of measurement of calibrators and control substances in biological samples of in vitro diagnostic medical devices
Source
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 Requirements
3.1 Appearance
The appearance should meet the following requirements.
a) The components of the kit should be complete and complete, and the liquid should not leak;
b) The marking shall be clear and easy to identify.
3.2 Traceability
The manufacturer should provide the source, assignment process and uncertainty of the calibrator used according to GB/T 21415 and related regulations.
3.3 accuracy
You can choose one of the following methods for verification (if applicable, the relative deviation method is preferred).
a) Relative deviation. measured using a certified reference material (CRM) or other recognized reference material that can be used to evaluate conventional methods
The relative deviation between the measured value and the marked value should be within ± 15%;
b) Recovery test. The recovery rate should be in the range of 85% to 115%.
3.4 detection limit
The detection limit should be ≤145pg/mL.
3.5 Linear
The linear range should cover 150pg/mL ~ 1000pg/mL. Within the linear range specified by the manufacturer, the correlation coefficient r should be ≥0.990.
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