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About the classification of product calibration fluids for clinical test and ana

Keyword: analyzer、   product  
Inputtime:January 10,2018

Original link:http://www.sda.gov.cn/WS01/CL0845/136760.html

Provinces, autonomous regions and municipalities Food and Drug Administration (Drug Administration):

In order to meet the needs of local medical device supervision and management work, the classification and definition of the calibration solution and cleaning solution for clinical test and analysis instruments are hereby notified as follows:

First, clinical testing of the instruments with calibrators (calibrator): which category the same category with the calibration of clinical testing of the instruments.

Second, the clinical inspection and analysis equipment used cleaning fluid: not as a medical device management.


                         State Food and Drug Administration Office
                           July 24, 2007

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