ADVIA CENTAUR TSH3-Ultra (TSH3-UL) - Registration No. 10345161732 ;. REAGENT FLEX TSH DIMENSION - Registration No. 10345161255 ;. TSH THIRD GENERATION IMMULITE / IMMULITE 1000 - Registration No. 10345160833 ;. TSH 3rd GENERATION IMMULITE 2000 - Registration No. 10345160834 의 안전성 경고

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

See the instructions for use of each product for more information. Consult the National Academy of Clinical Biochemistry: Laboratory Support for the Diagnosis and Monitoring of Thyroid Diseases: Guide # 18 for additional information on investigations of discordant TSH values. If you have any questions or need additional information, please contact the Customer Support Center at 0800-129-633. Link: Letter to the customer - http://portal.anvisa.gov.br/wps/wcm/connect/1ba0a0004066b7f78293d2dc5a12ff52/Carta_CC_13_06.pdf?MOD=AJPERES