June 22, 2011 Medical Appliances Production Approval Notice

Business Club June 23 News

No.
Acceptance number
Variety name
applicant
1
Standard 10-0422
CD3 Detection Kit (Immunohistochemistry)
Fuzhou Maixin Biotechnology Development Co., Ltd.
2
Standard 10-0456
Broad-spectrum Cytokeratin Assay Kit (Immunohistochemistry)
Fuzhou Maixin Biotechnology Development Co., Ltd.
3
Standard 10-0457
P53 Assay Kit (Immunohistochemistry)
Fuzhou Maixin Biotechnology Development Co., Ltd.
4
Standard 10-0458
CD20 Detection Kit (Immunohistochemistry)
Fuzhou Maixin Biotechnology Development Co., Ltd.
5
Standard 10-0459
CD34 Detection Kit (Immunohistochemistry)
Fuzhou Maixin Biotechnology Development Co., Ltd.
6
Standard 10-0460
S-100 Protein Assay Kit (Immunohistochemistry)
Fuzhou Maixin Biotechnology Development Co., Ltd.
7
Standard 10-0461
Smooth Muscle Actin Detection Kit (Immunohistochemistry)
Fuzhou Maixin Biotechnology Development Co., Ltd.
8
Standard 10-0463
Ki-67 Detection Kit (Immunohistochemistry)
Fuzhou Maixin Biotechnology Development Co., Ltd.
9
Standard 10-0587
Epithelial membrane antigen test kit (immunohistochemistry)
Fuzhou Maixin Biotechnology Development Co., Ltd.
10
Standard 10-0590
Hepatitis B virus YMDD gene mutation detection kit (PCR-fluorescence probe method)
Shanghai Kehua Bioengineering Co., Ltd.
11
Standard 10-1042
Hepatitis B virus surface antigen, surface antibody, e antigen, e antibody, core antibody detection kit (latex method)
Aibo Biomedical (Hangzhou) Co., Ltd.
12
Standard 10-1043
Hepatitis B virus surface antibody detection reagent (Latex method)
Aibo Biomedical (Hangzhou) Co., Ltd.
13
Standard 10-1046
Hepatitis B Virus Surface Antibody Detection Kit (Latex)
Aibo Biomedical (Hangzhou) Co., Ltd.
14
Standard 10-1050
Hepatitis B virus surface antigen test kit (colloidal gold method)
Aibo Biomedical (Hangzhou) Co., Ltd.
15
Standard 10-1231
ERG/TMPRSS2/ETV1/ETV4 Gene Abnormality Detection Kit (Fluorescence In Situ Hybridization)
Beijing Jin Pujia Medical Technology Co., Ltd.
16
Standard 10-1232
TOP2A Gene Amplification Detection Kit (Fluorescence in Situ Hybridization)
Beijing Jin Pujia Medical Technology Co., Ltd.
17
Standard 10-1480
Cytomegalovirus IgM Antibody Detection Kit (Enzyme-Linked Immunosorbent Assay)
Beijing Wantai Biopharmaceutical Co., Ltd.
18
Standard 11-0020
AFP quantitative determination kit (light forward method)
Beijing Jingjing Biotechnology Co., Ltd.
19
Standard 11-0041
Carcinoembryonic Antigen (CEA) Quantitative Assay Kit (Enzyme Immunoassay)
Beijing Jingjing Biotechnology Co., Ltd.
20
Standard 11-0043
Carbohydrate Antigen 125 (CA125) Assay Kit (Enzyme-linked Immunosorbent Assay)
Beijing Jingjing Biotechnology Co., Ltd.
twenty one
Standard 11-0044
AFP quantitative determination kit (chemiluminescence method)
Beijing Jingjing Biotechnology Co., Ltd.
twenty two
Standard 11-0045
AFP quantitative determination kit (Enzyme-linked immunosorbent assay)
Beijing Jingjing Biotechnology Co., Ltd.
twenty three
Standard 11-0046
Cytokeratin 19 Fragment (CYFRA21-1) Quantitative Assay Kit (Enzyme-linked Immunosorbent Assay)
Beijing Jingjing Biotechnology Co., Ltd.

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