CFDA Issued Eight Registration Guidelines

January 16th 2018, China Food and Drug Administration (CFDA) issued eight new registration guideline.

Registration guideline

Scope of application

Apolipoprotein A1 Determination Reagent Registration Technical Review Guideline.

载脂蛋白A1测定试剂注册技术审查指导原则.pdf

Apolipoprotein A1 Determination Reagent is transmission turbidimetry(ITA). It is  based on the principle of spectrophotometry and take advantage of fully automatic, semi-automatic biochemical analyzer or spectrophotometer for quantitative determination of apolipoprotein A1 in human serum and/or plasma in vitro. It is not applicable to the turbidimetric method. The management category of apolipoprotein A1 assay kit is class II and MD code is 6840.

Apolipoprotein B Determination Reagent Registration Technical Review Guideline.

载脂蛋白B测定试剂注册技术审查指导原则.pdf

Apolipoprotein B Determination Reagent is transmission turbidimetry(ITA). It is  based on the principle of spectrophotometry and take advantage of fully automatic, semi-automatic biochemical analyzer or spectrophotometer for quantitative determination of apolipoprotein B in human serum and/or plasma in vitro. It is not applicable to the turbidimetric method. Apolipoprotein B Determination Reagent is class II and MD code is 6840.

D-Dimer Determination Reagent (Immunoturbidimetric Method) Registration Technical Review Guideline.

D-二聚体测定试剂(免疫比浊法)注册技术审查指导原则.pdf

D-Dimer Determination Reagent in this guideline uses latex agglutination immunoturbidimetry as a basic principle and takes advantage of automatic and semi-automatic coagulation analyzer or automatic, semi-automatic biochemical analyzer or spectrophotometer. It is a reagent for quantitative analysis of d-dimer in human plasma samples was performed in the medical laboratory. D-Dimer Determination Reagent is class II and MD code is 6840.

 Alanine Aminotransferase Assay Reagent Registration Technical Review Guideline.

丙氨酸氨基转移酶测定试剂注册技术审查指导原则.pdf

The determination of alanine aminotransferase is used to determine the activity of alanine aminotransferase in human serum or plasma. Alanine Aminotransferase Assay Reagent is class II and MD code is 6840. 

Chemical Urinalysis Strips Registration Technical Review Guideline.

尿液分析试纸条注册技术审查指导原则.pdf

Chemical Urinalysis Strips in this guideline uses chemical reaction as a basic principle. Use the urine analyzer (including full automatic, semi-automatic urine analyzer, the same) or visual analysis for the medical laboratory conducts a semi-quantitative or qualitative examination of the composition of human urine. Chemical Urinalysis Strips is class II and MD code is 6840.

Homocysteine determination reagent Registration Technical Review Guideline.

同型半胱氨酸测定试剂注册技术审查指导原则.pdf

Homocysteine determination reagent is used for in vitro quantitative determination of homocysteine concentrations in human serum or plasma. It is class II and MD code is 6840.

Insulin Determination Reagent Registration Technical Review Guideline.

胰岛素测定试剂注册技术审查指导原则.pdf

Insulin Determination Reagent takes advantage of immunological method of antigen antibody response for quantitative determination of Insulin (Insulin) in human serum, plasma, or other body fluids. It is managed as class II.

C-Peptide Test Reagent Registration Technical Review Guideline.

C-肽测定试剂注册技术审查指导原则.pdf

C-Peptide Test Reagent takes advantage of immunological method of antigen antibody response for the in vitro quantitative determination of c-peptide (c-peptide) in human serum, plasma or other body fluids.  C-Peptide Test Reagent is class II and MD code is 6840. 

 

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