Chinese
About syphilis reagent and the announcement that product classification limits r
From;    Author:Stand originally

The country feeds medical inspect to fetters [2008]537 date

Medicines and chemical reagents of food of each province, municipality, municipality directly under the Central Government controls management board (medicines and chemical reagents controls management board) ,

Monitor the need that supervises the work to get used to medical apparatus and instruments, concerned unit of national bureau organization and expert diagnose reagent to reach its outside the body such as clinical to syphilis diagnostic reagent relevant product undertook classified limitting, show print and distribute to give you, ask comply with to carry out.


National provision medicines and chemical reagents controls management board
Two years on September 27


Syphilis diagnoses reagent to reach outside the body such as clinical diagnostic reagent
Product classification is limitted related its

1. Syphilis is clinical diagnostic reagent (colloid Selenium law) : The immunity outside the system that uses a kind of antibody of helicoid of the syphilis in syphilis patient serum, plasma or complete blood at determining to be able to be inspected is qualitative experimental reagent. As Ⅲ kind management of medical apparatus and instruments. Classify encode: 6840.

2. Third liver is clinical diagnostic reagent (comb law of type enzymatic mark) : Use at qualitative detect virus of the third in person serum or plasma hepatitis (HCV) the rapid test of IgG antibody. As Ⅲ kind management of medical apparatus and instruments. Classify encode: 6840.

3. Check of law of analyse of layer of antibody of opposite sex of be addicted to of disease of contagious monocyte grow in quantity checks agent box: Qualitative detect antibody of opposite sex of be addicted to of disease of grow in quantity of monocyte of the infectivity in serum, serous, complete blood, it is the auxiliary method of disease of grow in quantity of diagnostic infectivity monocyte. As Ⅲ kind management of medical apparatus and instruments. Classify encode: 6840.

4. Check of antibody of arched bug IgM checks agent box: Use adsorption of enzymatic couplet immunity to determine legal sex detects the antibody of arched bug IgM in person serum. As Ⅲ kind management of medical apparatus and instruments. Classify encode: 6840.

5. Pure herpes virus (Ⅱ ) IgM antibody diagnoses reagent box: Through detecting whether is pure herpes virus contained in person serum or serous example (Ⅱ ) IgM antibody, used at near future of auxiliary diagnostic patient to whether contract virus of Ⅱ pure herpes. As Ⅲ kind management of medical apparatus and instruments. Classify encode: 6840.

6. Pure herpes virus (Ⅰ ) IgM antibody diagnoses reagent box: Through detecting whether is pure herpes virus contained in person serum or serous example (Ⅰ ) IgM antibody, used at near future of auxiliary diagnostic patient to whether contract virus of Ⅰ pure herpes. As Ⅲ kind management of medical apparatus and instruments. Classify encode: 6840.
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