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Till February 2014, ZECEN BIOTECH was awardedregistration certificates for 30 full-automatic chemiluminescence reagents,including 23 quantitative detection reagents and 7 general purpose reagents.The details are listed as follows:
Quantitativedetection reagents
Item Name | Registration No. | Category |
TT3 quantitative detection Kit（CLIA） | Jiangsu FDA (Approved) 2013 No. 2401523 | II |
FT3 quantitative detection Kit（CLIA） | Jiangsu FDA (Approved) 2013 No. 2401530 | II |
TT4 quantitative detection Kit（CLIA） | Jiangsu FDA (Approved) 2013 No. 2401526 | II |
FT4 quantitative detection Kit（CLIA） | Jiangsu FDA (Approved) 2013 No. 2401536 | II |
TSH quantitative detection Kit（CLIA） | Jiangsu FDA (Approved) 2013 No. 2401527 | II |
E2 quantitative detection Kit（CLIA） | Jiangsu FDA (Approved) 2013 No. 2401519 | II |
P quantitative detection Kit（CLIA） | Jiangsu FDA (Approved) 2013 No. 2401528 | II |
T quantitative detection Kit（CLIA） | Jiangsu FDA (Approved) 2013 No. 2401522 | II |
Total-hCGβ quantitative detection Kit（CLIA） | Jiangsu FDA (Approved) 2013 No. 2401525 | II |
F-hCGβ quantitative detection Kit（CLIA） | Jiangsu FDA (Approved) 2013 No. 2401517 | II |
PRL quantitative detection Kit（CLIA） | Jiangsu FDA (Approved) 2013 No. 2401529 | II |
FSH quantitative detection Kit（CLIA） | Jiangsu FDA (Approved) 2013 No. 2401539 | II |
LH quantitative detection Kit（CLIA） | Jiangsu FDA (Approved) 2013 No. 2401532 | II |
C-P quantitative detection Kit（CLIA） | Jiangsu FDA (Approved) 2013 No. 2401537 | II |
INS quantitative detection Kit（CLIA） | Jiangsu FDA (Approved) 2013 No. 2401521 | II |
β2-MG quantitative detection Kit（CLIA） | Jiangsu FDA (Approved) 2013 No. 2401538 | II |
Hgh quantitative detection Kit（CLIA） | Jiangsu FDA (Approved) 2013 No. 2401520 | II |
TGAb quantitative detection Kit（CLIA） | Jiangsu FDA (Approved) 2013 No. 2401524 | II |
TPOAb quantitative detection Kit（CLIA） | Jiangsu FDA (Approved) 2013 No. 2401533 | II |
PⅢNP quantitative detection Kit（CLIA） | Jiangsu FDA (Approved) 2013 No. 2401535 | II |
CⅣquantitative detection Kit（CLIA） | Jiangsu FDA (Approved) 2013 No. 2401534 | II |
LN quantitative detection Kit（CLIA） | Jiangsu FDA (Approved) 2013 No. 2401531 | II |
HA quantitative detection Kit（CLIA） | Jiangsu FDA (Approved) 2013 No. 2401518 | II |
Generalpurpose reagents
Item Name | Registration No. |
Cleansing solution for chemiluminescence system | Jiangsu Wuxi FDA (instrument) 2013 No. 1400025 |
Sample dilution 1 for chemiluminescence system | Jiangsu Wuxi FDA (instrument) 2013 No. 1400026 |
Sample dilution 2 for chemiluminescence system | Jiangsu Wuxi FDA (instrument) 2013 No. 1400027 |
Sample dilution 3 for chemiluminescence system | Jiangsu Wuxi FDA (instrument) 2013 No. 1400028 |
Sample dilution 4 for chemiluminescence system | Jiangsu Wuxi FDA (instrument) 2013 No. 1400029 |
Sample dilution for Ferritin | Jiangsu Wuxi FDA (instrument) 2013 No. 1400030 |
Chemiluminescent substrate solution for full automatic immunodetection | Jiangsu Wuxi FDA (instrument) 2013 No. 1400041 |