The results of the second batch of medical device spot check were announced: three medical equipment application items will not be registered
On December 16, the State Food and Drug Administration issued the second batch of medical device clinical trial supervision and spot check results, the results showed that including Anhui Tongke Biotechnology Co., Ltd., Germany Roche Diagnostics GmbH, Japan LSI Medience Corporation three test kits There are real problems in clinical trials. The following is the full text of the announcement:
First, the inspection results
(1) Human papillomavirus (15 types) nucleic acid typing test kit of Anhui Tongke Biotechnology Co., Ltd. (PCR multicolor fluorescence method) (Acceptance No.: CSZ1600248)
In the clinical trial conducted by Shanghai Tongji Hospital: in the positive samples, sample numbers 1200380337 and 1200376478 were the same samples collected on December 1, 2015 and March 7, 2016, respectively. The sample numbers 1200374512 and 1200374509 were the same. Case 534398 samples taken on November 22, 2015 and November 23, 2015, respectively, sample numbers 1200412276 and 1200376957 were samples taken from the same case G03965533 on October 12, 2015 and February 15, 2016, respectively. No. 1200380689 and 1200376867 are samples taken in the same case M05394117 on November 9, 2015 and February 18, 2016, respectively.
In the clinical trials conducted by the Shanghai Tenth People's Hospital: in the positive samples, sample numbers 0901077658 and 0901122964 were samples taken by the same case 21177667 on October 27, 2015 and January 18, 2016, respectively, sample numbers 0901084388 and 0901122424 Samples collected for the same case 51470794 on January 6, 2016 and February 5, 2016; sample numbers 0901082289 and 0901122245 were samples taken on October 12, 2015 and February 18, 2016, respectively, for the same case 21223939 The former test result is HPV52 positive, and the latter test result is negative.
(2) Human T lymphocyte virus type 1 and type 2 antibody detection kit (electrochemiluminescence method) (acceptance number: JSZ1600012) from Roche Diagnostics GmbH, Germany, and agent for Roche Diagnostics (Shanghai) Co., Ltd.
In the clinical trial conducted by the First Affiliated Hospital of Sun Yat-sen University: among the 7 positive samples of the test reagents, 3 of the comparative reagents and the third-party reagents were negative. The 3 specimens were collected from the same patient on the same day. Different blood sample specimens; of the 350 negative samples of test reagents, 2 specimens were derived from 2 different blood specimens collected from the same patient on the same day, and 227 specimens were derived from 227 specimens of different blood samples collected from 52 patients on different dates. .
(3) Soluble CD14 subtype detection kit (Chemical Luminescence Immunoassay) (acceptance number: JSZ1600078) of LSI Medience Corporation of Japan, the agent is Guangzhou Xinyi Instrument Co., Ltd.
In the clinical trials conducted by the Affiliated Hospital of Jining Medical College: among the 350 clinical trial samples, 6 blood culture positive samples were samples taken by 3 patients on different dates, and 2 blood culture positive samples were samples of the same patient. The measurement was repeated twice, and 32 samples of 16 blood culture-negative samples were repeatedly measured twice for each of the 16 patients.
In the clinical trial conducted by Shanghai First People's Hospital: among the 349 clinical trial samples, 5 blood culture positive samples were collected from 2 patients on different dates, and 4 blood culture negative samples were derived from 2 patients. Date collection, 3 blood culture positive samples and 4 blood culture negative samples were collected from 3 patients on different dates.
What is Indoor PTZ Camera
PTZ: In the security monitoring application, it is the abbreviation of Pan/Tilt/Zoom, representing the pan tilt omnidirectional (up and down, left and right) movement, lens zoom and zoom control.
PTZ: In the security monitoring application, it is the abbreviation of Pan/Tilt/Zoom, representing the pan tilt omnidirectional (up and down, left and right) movement, lens zoom and zoom control.Automatic tracking is divided into three types: one is through embedded video encoder, also known as intelligent visual server; the other is PC software; the other is to directly write the tracking algorithm to DSP chip, and then design the DSP chip as a hardware circuit on the high-speed ball motherboard, and the high-speed ball is directly read. Among the three types, the third type is used most in the current market.
The intelligent vision PTZ automatic tracking and monitoring system consists of an intelligent vision server (responsible for intelligent analysis and command) and a high-speed spherical camera (responsible for tracking targets). The automatic PTZ intelligent tracking function enables the camera to automatically PTZ drive its own PTZ and zoom lens, and automatically control the PTZ camera to rotate the PTZ in all directions and zoom the lens, and perform visual oriented automatic tracking for the locked moving target, so as to ensure that the tracking target continues to appear in the center of the lens with a close-up image, so that the security personnel can see the information more clearly, It can also be used for obtaining evidence afterwards. The automatic PTZ tracking module makes up for the narrow field of vision of fixed camera monitoring, which is an essential function of a perfect security monitoring system.
The intelligent vision PTZ automatic tracking and monitoring system has the target analysis function, and is equipped with a high-resolution camera, a large magnification optical zoom lens and a high speed PTZ, which can automatically capture suspicious targets quickly and accurately. By setting the preset position intelligent vision PTZ automatic tracking monitoring system, the preset position scanning, automatic cruise and other functions can be realized, and many special requirements of intelligent monitoring can also be realized. In addition, the intelligent vision PTZ automatic tracking and monitoring system also has the advantages of beautiful appearance and strong concealment, so it is very suitable for public security intelligent monitoring applications in airports, squares, rail transit, villas, government administrative units, military regions, museums and other types of places.
The automatic PTZ tracking and monitoring system integrates optics, electronics, machinery, information processing and network, and is composed of camera, power transmission, motion control device, image analysis, recognition, compression and communication based on high-speed parallel processing. It has the functions of video camera, position control, orientation and lens preset, moving object detection, recognition and tracking, flame and smoke detection and alarm, etc. It can be widely used in buildings, banks, airports, stations, customs, transportation, power, factories and mining enterprises and other security monitoring occasions.
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