|
US$259.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 1242-2014: α-Hydroxybutyrate dehydrogenase test reagent (kit)
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1242-2014 | English | 259 |
Add to Cart
|
3 days [Need to translate]
|
α-Hydroxybutyrate dehydrogenase test reagent (kit)
| Valid |
YY/T 1242-2014
|
PDF similar to YY/T 1242-2014
Basic data | Standard ID | YY/T 1242-2014 (YY/T1242-2014) | | Description (Translated English) | ��-Hydroxybutyrate dehydrogenase test reagent (kit) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100 | | Word Count Estimation | 11,186 | | Date of Issue | 6/17/2014 | | Date of Implementation | 7/1/2015 | | Quoted Standard | GB 3100; YY/T 0316; YY/T 0466.1 | | Regulation (derived from) | China Food and Drug Administration in 2014 Bulletin No. 30 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This Standard applies to the use of continuous monitoring method for serum or plasma ��- hydroxybutyrate dehydrogenase activity quantitative detection of ��- hydroxybutyrate dehydrogenase assay reagent (box), including manual reagents and in semi-automatic | YY/T 1242-2014: α-Hydroxybutyrate dehydrogenase test 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.
α-Hydroxybutyrate dehydrogenase test reagent (kit)
ICS 11.100
C44
People's Republic of China pharmaceutical industry standards
α- hydroxybutyrate dehydrogenase assay reagent (kit)
Issued on. 2014-06-17
2015-07-01 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, Shanghai Fuxing Changzheng Medical Science Co., BIOSINO biotech stocks
Parts Limited, Beijing Leadman Biochemistry Co., Ltd.
The main drafters of this standard. Wang Jun, Duhai Ou, Wu Jie, Yuecai Qin, Wang Lanzhen.
α- hydroxybutyrate dehydrogenase assay reagent (kit)
1 Scope
This standard specifies the α- hydroxybutyrate dehydrogenase assay reagent (box) terms and definitions, requirements, test methods, labels, brochures, package
Loading, transportation and storage requirements.
This standard applies to the use of continuous monitoring method for serum or plasma α- hydroxybutyrate dehydrogenase activity quantitative detection of α- hydroxybutyrate off
Catalase assay reagent (kit), including manual reagents and on the semi-automatic biochemical analyzer used.
This standard does not apply to dry α- hydroxybutyrate dehydrogenase assay reagent (kit).
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 3100 International System of Units and Its Application
YY/T 0316 Medical Devices Risk Management for Medical Device Applications
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
Continuous monitoring method continuous-monitoring
Under optimum conditions the enzyme reaction, multi-point monitoring throughout the course of the enzymatic reaction product or a reaction in the substrate due to changes over time
Case, the reaction rate constant period, in the initial reaction rate per unit time of enzyme activity concentration of the enzyme was calculated.
4 Requirements
4.1 Appearance
In line with the provisions of the company's normal appearance requirements.
4.2 PACKING
Loading amount of the liquid reagent to be less than indicated value.
4.3 reagent blank
4.3.1 Reagent blank absorbance
At 37 ℃, 340nm wavelength, under 1cm light path conditions, absorbance of the reagent blank should not be less than 1.1.
4.3.2 Reagent blank absorbance change rate
At 37 ℃, 340nm wavelength, 1cm light path condition with normal saline as the test sample was added to the reagent, the reagent blank absorbance
Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 1242-2014_English be delivered?Answer: Upon your order, we will start to translate YY/T 1242-2014_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time. Question 2: Can I share the purchased PDF of YY/T 1242-2014_English with my colleagues?Answer: Yes. The purchased PDF of YY/T 1242-2014_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet. Question 3: Does the price include tax/VAT?Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countriesQuestion 4: Do you accept my currency other than USD?Answer: Yes. If you need your currency to be printed on the invoice, please write an email to [email protected]. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.
|