Securities code: 688389 securities abbreviation: Shenzhen Lifotronic Technology Co.Ltd(688389) Announcement No.: 2022-001
Shenzhen Lifotronic Technology Co.Ltd(688389)
Announcement on holding subsidiary's obtaining medical device registration certificate
The board of directors and all directors of the company guarantee that the contents of this announcement are not false or misleading
Make statements or major omissions, and bear legal responsibility for the authenticity, accuracy and completeness of their contents according to law
Ren.
Chongqing pumenchuang Biotechnology Co., Ltd., a holding subsidiary of Shenzhen Lifotronic Technology Co.Ltd(688389) (hereinafter referred to as "the company"), recently received 35 medical device registration certificates of the people's Republic of China (in vitro diagnostic reagents) issued by Chongqing drug administration. The details are as follows:
1、 Details of medical device registration certificate
Product name registration certificate registration certificate intended use
No. validity period classification
Vitamin B12 was used for in vitro quantitative determination of vitamin B12 in human serum (vitamin B12) Yuxi zhuzhuzhun date - December 2026
Determine the amount of the kit (containing chemiluminescence method on day 2021240033523 (vitamin B12).
Determination of interleukin-6 test Yuxi injection standard December 24, 2021 is used for quantitative determination of interleukin-6 in human serum 2 dose box in vitro (electrochemical hair 20212400336 - December 2026)
Light method) IL-6 stat23 (IL-6).
It is used for quantitative determination of cancer antigen 72-4 (CA72-4) in human serum or plasma in vitro. It is mainly used to measure the 23 day treatment effect of the (CA72-4) dynamic monitoring 3 Kit (electrochemical class II measurement from December 20212400337 to December 2026) for patients with malignant tumors on December 24, 2021. It can not be used as the basis for early diagnosis or confirmation of malignant tumors, and should not be used for tumor screening of ordinary people.
D-dimer determination test was used to quantitatively determine the content of D-dimer in 4 dose boxes of human plasma in vitro on December 24, 2021 (D-dimer optical method in class II of electrochemical FA Yu machinery injection date December 2026).
STAT
Type 5B natriuretic peptide Yuxi injection standard December 24, 2021 class II reagent for quantitative determination of human plasma (BNP) in vitro
Box (electrochemiluminescence) 23 day content.
Method)
Determination of B-type natriuretic peptide on December 24, 2021 was used to quantitatively determine the content of B-type natriuretic peptide (BNP) in human plasma 6 kit in vitro (electrochemical Yuxi injection standard date - luminescence method of class II in December 2026).
STAT
It is used for quantitative determination of neuron specific enolase (NSE) in human serum in vitro. It is mainly used for dynamic monitoring of patients with malignant tumor detected by NSE and approved by Yuxi injection on December 24, 2021. The 7-fixed Kit (electrochemical class II from December 20212400341 to December 2026 to assist in judging the disease process or therapeutic luminescence method) has a therapeutic effect on 23 days. It can not be used as the basis for early diagnosis or diagnosis of malignant tumor, and is not suitable for tumor screening of ordinary people.
Human chorionic gonadotropin December 24, 2021 is used for quantitative determination of human serum 8 hormone determination kit in vitro. Yuxi zhuzhuzhun date - December 2026 is the content of human chorionic gonadotropin (electrochemiluminescence) in class II or plasma on December 24, 2021240034223. HCG stat
It is used for quantitative determination of gastrin releasing peptide precursor (ProGRP) in human serum or plasma in vitro. It is mainly used to measure the schedule or treatment effect of the dynamic 9-Determination Kit (electrochemical monitoring of class II state from December 20212400343 to December 2026) for patients with malignant tumors on December 24, 2021, It can not be used as the basis for early diagnosis or diagnosis of malignant tumors, and should not be used for tumor screening in the general population.
It is used for quantitative determination of carbohydrate antigen 19-carbohydrate antigen 19-99 (CA19-9) in human serum or plasma in vitro. It is mainly used for the dynamic monitoring of the therapeutic effect of the 10 agent box (electrochemistry hair 20212400344 - class II test in December 2026) for the patients with malignant tumors on December 24, 2021 (CA19-9). It can not be used as the basis for early diagnosis or confirmation of malignant tumors, and should not be used for tumor screening of ordinary people.
The progesterone determination kit was used for quantitative determination in vitro of prog stat23 in human serum 11 (electrochemiluminescence 20212400345 - prog method in class II or plasma in December 2026).
Hypersensitive C-reactive protein December 24, 2021 for in vitro quantitative determination of human serum 12 determination kit (dianyuxi zhuzhuzhuzhuzhun date December 24, 2026 class II or C-reactive protein in plasma
Chemiluminescence method) hs-2021240034623 (CRP).
CRP STAT
Heart type fatty acid junction December 24, 2021 was used to quantitatively determine the amount of H-FABP stat in human serum 13 protein determination reagent Yuxi zhuzhuzhun date December 2026 class II or heart type fatty acid kit in plasma (Electrochemiluminescence Method for the content of binding protein (H-FABP) on December 24, 2021240034723).
It is used for quantitative determination of cancer antigen 15-3 (CA15-3) in human serum or plasma in vitro. It is mainly used for dynamic monitoring 14 agent box (electrochemiluminescence 20212400) for patients with malignant tumors on December 24, 2021
