Path: Home > YY/T > Page1 > YY/T 1964-2025 || Home > Standard_List > YY/T > Page1 > YY/T 1964-2025 Price & DeliveryUS$189.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 1964-2025: Tacrolimus testing kit
Status: Valid
| Std ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status |
| YY/T 1964-2025 | English | 189 |
Add to Cart
|
3 days [Need to translate]
|
Tacrolimus testing kit
| Valid |
Standard similar to YY/T 1964-2025 YY/T 1713 | YY/T 1709 | YY/T 1721 | YY/T 1961 | YY/T 1958 | Basic data | Standard ID | YY/T 1964-2025 (YY/T1964-2025) | | Description (Translated English) | Tacrolimus testing kit | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100.10 | | Word Count Estimation | 9,947 | | Date of Issue | 2025-06-18 | | Date of Implementation | 2026-07-01 | | Issuing agency(ies) | National Medical Products Administration | | Summary | This standard specifies the requirements, marking, labeling, and instructions for use of tacrolimus assay kits, as well as packaging, transportation, and storage, and describes the corresponding test methods. This document applies to kits for the quantitative determination of tacrolimus content in human whole blood using chemiluminescence immunoassay, homogeneous enzyme immunoassay, immunoturbidimetry, and liquid chromatography-tandem mass spectrometry. | YY/T 1964-2025: Tacrolimus testing 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.
ICS 11.100.10
CCSC44
Pharmaceutical Industry Standards of the People's Republic of China
Tacrolimus Assay Kit
Published on 2025-06-18
Implemented on July 1, 2026
National Medical Products Administration issued
Foreword
This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1.Structure and Drafting Rules of Standardization Documents".
Drafting.
Please note that some content in this document may involve patents. This document is published...
The organization is not responsible for identifying patents.
This document was proposed by the National Medical Products Administration.
This document is under the jurisdiction of the National Technical Committee on Standardization of Medical Clinical Laboratory and In Vitro Diagnostic Systems (SAC/TC136).
This document was drafted by. Beijing Institute for Medical Device Testing (Beijing Medical Biological Protective Equipment Testing and Research Center), Beijing Medical...
Medical Device Evaluation and Inspection Center, Beijing Chaoyang Hospital affiliated to Capital Medical University, Shandong Yingsheng Biotechnology Co., Ltd., Shimadzu Enterprise Management
(China) Co., Ltd., Beijing BGI Genomics Co., Ltd., Abbott Trading (Shanghai) Co., Ltd., Shanghai Yunze Biotechnology Co., Ltd.
Limited Company.
The main drafters of this document are. Li Shengmin, Sun Rong, Li Pengfei, Mi Zhaoyuan, Li Changkun, Zhang Shenyan, Wu Xiaojun, Lin Weijing, and Zhao Bingfeng.
Wu Kechun.
Tacrolimus Assay Kit
1 Scope
This document specifies the requirements for tacrolimus assay kits, including labeling, marking, instructions for use, packaging, transportation, and storage.
The corresponding test method.
This document applies to the quantitative determination of human whole blood using chemiluminescence immunoassay, homogeneous enzyme immunoassay, immunoturbidimetry, and liquid chromatography-tandem mass spectrometry.
A reagent kit containing tacrolimus.
2 Normative references
The contents of the following documents, through normative references within the text, constitute essential provisions of this document. Dated citations are not included.
For references to documents, only the version corresponding to that date applies to this document; for undated references, the latest version (including all amendments) applies.
This document.
GB/T 191 Pictorial Symbols for Packaging and Storage
GB/T 21415 Metrological Traceability of Calibrators and Control Substances for the Measurement of Quantities in Biological Samples of In Vitro Diagnostic Medical Devices
GB/T 29791.2 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 2.Professional in vitro diagnostic reagents
3 Terms and Definitions
This document does not contain any terms or definitions that need to be defined.
4 Requirements
4.1 Appearance
Manufacturers should specify appropriate appearance requirements based on the packaging characteristics of their products. Generally, this should include descriptions of the components and properties of the reagent kit.
The requirements for internal and external packaging, labels, etc. are clearly defined.
4.2 Traceability
If the kit contains calibrators, the manufacturer shall provide information on the source, assignment process, and measurement of the calibrators in accordance with GB/T 21415 and relevant regulations.
Information on uncertainties and other related topics.
4.3 Filling Quantity
The liquid volume should be no less than the indicated value.
4.4 Linear
Kits based on mass spectrometry principles should meet requirements a), while kits based on other principles should meet requirements b).
a) Within the range of [1.0, 30.0] ng/mL, the correlation coefficient (r) ≥ 0.990; within the range of [1.0, 3.0] ng/mL, the absolute linear deviation should not exceed [0.990].
For values exceeding ±0.45 ng/mL, the relative linear deviation should not exceed ±15.0% within the range of (3.0, 30.0) ng/mL.
b) Within the range of [2.0, 30.0] ng/mL, the correlation coefficient (r) ≥ 0.990; within the range of [2.0, 3.0] ng/mL, the specified absolute deviation is [missing value].
Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 1964-2025_English be delivered?Answer: Upon your order, we will start to translate YY/T 1964-2025_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 1964-2025_English with my colleagues?Answer: Yes. The purchased PDF of YY/T 1964-2025_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 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. |