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ZECEN BIOTECH was awarded registration certificates for 30 full-automatic chemiluminescence reagents

time:2021-05-14   visits:1780

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 KitCLIA

Jiangsu FDA (Approved) 2013 No. 2401523

II

FT3 quantitative detection KitCLIA

Jiangsu FDA (Approved) 2013 No. 2401530

II

TT4 quantitative detection KitCLIA

Jiangsu FDA (Approved) 2013 No. 2401526

II

FT4 quantitative detection KitCLIA

Jiangsu FDA (Approved) 2013 No. 2401536

II

TSH quantitative detection KitCLIA

Jiangsu FDA (Approved) 2013 No. 2401527

II

E2 quantitative detection KitCLIA

Jiangsu FDA (Approved) 2013 No. 2401519

II

P quantitative detection KitCLIA

Jiangsu FDA (Approved) 2013 No. 2401528

II

T quantitative detection KitCLIA

Jiangsu FDA (Approved) 2013 No. 2401522

II

Total-hCGβ quantitative detection KitCLIA

Jiangsu FDA (Approved) 2013 No. 2401525

II

F-hCGβ quantitative detection KitCLIA

Jiangsu FDA (Approved) 2013 No. 2401517

II

PRL quantitative detection KitCLIA

Jiangsu FDA (Approved) 2013 No. 2401529

II

FSH quantitative detection KitCLIA

Jiangsu FDA (Approved) 2013 No. 2401539

II

LH quantitative detection KitCLIA

Jiangsu FDA (Approved) 2013 No. 2401532

II

C-P quantitative detection KitCLIA

Jiangsu FDA (Approved) 2013 No. 2401537

II

INS quantitative detection KitCLIA

Jiangsu FDA (Approved) 2013 No. 2401521

II

β2-MG quantitative detection KitCLIA

Jiangsu FDA (Approved) 2013 No. 2401538

II

Hgh quantitative detection KitCLIA

Jiangsu FDA (Approved) 2013 No. 2401520

II

TGAb quantitative detection KitCLIA

Jiangsu FDA (Approved) 2013 No. 2401524

II

TPOAb quantitative detection KitCLIA

Jiangsu FDA (Approved) 2013 No. 2401533

II

PNP quantitative detection KitCLIA

Jiangsu FDA (Approved) 2013 No. 2401535

II

Cquantitative detection KitCLIA

Jiangsu FDA (Approved) 2013 No. 2401534

II

LN quantitative detection KitCLIA

Jiangsu FDA (Approved) 2013 No. 2401531

II

HA quantitative detection KitCLIA

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


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