CFDA Issued Four Registration Guidelines

Registration guideline

Scope of application

Automatic blood type analyzer Registration guideline.

全自動血型分析儀注冊技術審查指導原則.pdf

This guideline can apply to automatic blood type analyzer that conduct Blood group identification, antibody screening, cross-matching and etc. for the human blood type through test tube method, microporous plate method or column agglutination method.

ABO、RhD blood type antigen detection card(Column agglutination method) Registration guideline

ABO、RhD血型抗原檢測卡（柱凝集法）注冊技術審查指導原則.pdf

This guideline can apply to ABO、RhD blood type antigen detection card(Column agglutination method) and column agglutination method blood type detection card including ABO、RhD blood type antigen detection usage.

Human Epidermal Growth Factor receptor 2 gene amplification test kit (fluorescence in situ hybridization) Registration guideline.

人表皮生長因子受體2基因擴增檢測試劑盒（熒光原位雜交法）注冊技術審查指導原則.pdf

This guideline can apply to the fluorescence in situ hybridization method used to detect HER2 gene amplification in the biopsy samples and biopsy samples. It includes HER2 gene average copy number (single signal),HER2 gene average copy number and the ratio of the average copy number of chromosome 17 (CEP17) in chromosome 17 of the gene (double signal).

Hepatitis c viral nucleic acid genotyping test kit Registration guideline

丙型肝炎病毒核酸基因分型檢測試劑盒注冊技術審查指導原則.pdf

This guideline can apply to HCV nucleic acid genotyping test kit that based on PCR（polymerase chain reaction）method.