Professional focus on serving the medical laboratory community
JINAN LANJIE BIOTECHNOLOGY CO.,LTD.
Continuous innovation of products, continuous diversification and technological upgrading
JINAN LANJIE BIOTECHNOLOGY CO.,LTD.
Good news! Lanjie Biology once again passed the "High-tech Enterprise" certification
Recently, the Office of the National High-tech Enterprise Recognition and Management Leading Group Office announced the second batch of high-tech enterprise registration lists for 2023 certification by the Shandong Provincial Recognition Agency. After enterprise qualification declaration, tripartite qualification appraisal, street district preliminary review recommendation, enterprise on-site review, expert review and identification, publicity and filing, Jinan Lanjie Biotechnology Co., Ltd. passed the test again by virtue of its innovative technological advantages and standardized quality management system. "High-tech Enterprise" certification!
08
2024
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01
The 19th China International Laboratory Medicine and Blood Transfusion Instruments and Reagents Expo
The 19th China International Laboratory Medicine and Transfusion Instruments and Reagents Expo (CACLP) with the theme of "Brand Brilliance and Glory in the Future", and the 2nd China International IVD Upstream Raw Materials Manufacturing and Distribution Supply Chain Expo (CISCE) will be held in October 2022 It was successfully held at Nanchang Greenland International Expo Center from the 26th to the 28th.
08
2024
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01
Submission requirements for in vitro diagnostic reagent declaration data sheets/labels
The state continues to strengthen the registration management of medical devices, and the requirements for the materials submitted by our applicants are "complete materials and meet the statutory form requirements". Today, let's talk about the submission requirements of the instructions/label materials in the in vitro diagnostic reagent application materials.
25
2023
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09
Status analysis of registration management of in vitro diagnostic reagent products in China
In vitro diagnostic reagents refer to reagent products used for in vitro testing of human samples. Except for in vitro diagnostic reagents used for blood source screening and radionuclide labeling, all of them belong to the supervision of medical devices. It includes reagents, kits, calibrators, quality control products, etc., with the ability to predict diseases, diagnose diseases and prognosis observation and health status evaluation, which plays an important role in improving the quality of medical care and reducing medical costs. Therefore, it is very important to establish a sound regulatory system to ensure the standardization of in vitro diagnostic reagent filing and registration and product safety and effectiveness.
21
2023
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08
In vitro diagnosis is a branch of the medical device industry. It refers to a unified detection system composed of relevant medical clinical diagnostic instruments and supporting detection reagents outside the human body. Through the detection of human samples (blood, body fluids, tissues, etc.) to obtain clinical diagnostic information, and then to judge the disease or body function of products and services.
22
2023
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04
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