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YY/T 1583-2018 English PDF

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US$139.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 1583-2018: Folate testing kit (chemiluminescent immunoassay)
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1583-2018	139	Add to Cart	3 days	Folate testing kit (chemiluminescent immunoassay)	Valid

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Basic data

Standard ID: YY/T 1583-2018 (YY/T1583-2018)
Description (Translated English): Folate testing kit (chemiluminescent immunoassay)
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C44
Classification of International Standard: 11.100
Word Count Estimation: 7,773
Date of Issue: 2018-02-24
Date of Implementation: 2019-03-01
Quoted Standard: GB/T 191; GB/T 21415; GB/T 29791.2
Regulation (derived from): China Food and Drug Administration announced No. 27 of 2018
Issuing agency(ies): State Food and Drug Administration
Summary: This standard specifies the requirements, test methods, labels, labels and instructions for use, packaging, transportation, and storage of folic acid determination kits (chemiluminescence immunoassay) (hereinafter referred to as "kits"). This standard applies to a kit for the quantitative determination of folic acid in human serum using chemiluminescence immunoassay as a principle, including enzymatic and non-enzymatic chemistry using microplates, tubes, magnetic particles, beads, and plastic beads as carriers. Luminescence immunoassay kit. This standard does not apply to: a) Determination of human folic acid content in red blood cells; b) Folic acid calibrators and folic acid control products intended for sale alone; c) Biochips based on chemiluminescence immunoassay.

YY/T 1583-2018: Folate testing kit (chemiluminescent 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.
Folate testing kit(chemiluminescent immunoassay) ICS 11.100 C44 People's Republic of China Pharmaceutical Industry Standard Folic acid assay kit (chemiluminescence immunoassay) Published on.2018-02-24 2019-03-01 implementation State Food and Drug Administration issued

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of the contents of this document may involve patents. Publication of this document The organization is not responsible for identifying these patents. This standard was proposed by the State Food and Drug Administration. This standard is under the jurisdiction of the National Medical Clinical Laboratory and the In vitro Diagnostic System Standardization Technical Committee (SAC/TC136). This standard was drafted. Beijing Medical Device Inspection Institute, Abbott Trade (Shanghai) Co., Ltd., Shenzhen New Industry Biomedical Engineering Limited. The main drafters of this standard. Zou Yingying, Yan Juan, Wang Xuefeng, Yuan Jinyun. Folic acid assay kit (chemiluminescence immunoassay)

1 Scope

This standard specifies the requirements, test methods and standards for the folic acid determination kit (chemiluminescence immunoassay) (hereinafter referred to as "kit"). Identification, labeling and instructions for use, packaging, transportation and storage. This standard applies to the kit for quantitative determination of folic acid in human serum by chemiluminescence immunoassay, including microplates, An enzymatic and non-enzymatic chemiluminescence immunoassay kit for the determination of tubes, magnetic particles, microbeads, and plastic beads. This standard does not apply to. a) determination of folic acid content in human erythrocytes; b) Folic acid calibrators and folic acid controls intended for sale separately; c) Biochips based on chemiluminescence immunoassay.

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article. Pieces. For undated references, the latest edition (including all amendments) applies to this document. GB/T 191 packaging storage and transportation icon GB/T 21415 in vitro diagnostic medical device biological sample medium quantity measurement calibrator and control substance evaluation Source GB/T 29791.2 Information provided by in vitro diagnostic medical device manufacturers (labeling) Part 2. Professional in vitro diagnostic reagents

3 requirements

3.1 Appearance The components of the kit should be complete and complete, and the liquid should be free of leakage. 3.2 Traceability The manufacturer shall provide the source, valuation process and measurement uncertainty of the folic acid calibrator used according to GB/T 21415 and relevant regulations. Degree and other content. 3.3 Accuracy You can use one of the following methods to verify (if applicable, the method of relative bias is preferred). a) Relative Deviation. Determined using a Certified Reference Material (CRM) that can be used to evaluate conventional methods. The deviation should be within ±15%; b) Recovery test. The recovery rate should be in the range of [85%, 115%]. 3.4 Checkout limit The detection limit should be no more than 1.0 ng/mL. ......

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Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY/T 1583-2018_English be delivered?

Answer: Upon your order, we will start to translate YY/T 1583-2018_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 1583-2018_English with my colleagues?

Answer: Yes. The purchased PDF of YY/T 1583-2018_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+ countries

Question 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 Sales@ChineseStandard.net. 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.