U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
selective medium for the screening and identification - Product Code NJR
원인
Fda has determined that the product requires 510(k) clearance to continue marketing/distribution in the united states.
조치
The firm, Biomerieux, sent an "Urgent Product Removal Notice" dated November 23, 2015 to its consignees. The letter described the product, problem and actions to be taken. The consignees were instructed to confirm that the letter has been distributed and reviewed by all appropriate personnel, discontinue and discard any remaining inventory, store letter with your bioMerieux documentation and complete the attached Acknowledgement Form via fax to: (919) 620-3306 attention of: bioMerieux NA ComOps QA/RA.
If you have any questions or concerns, please contact your local bioM¿rieux Clinical Customer Service organization at (800) 682-2666.
US Distribution to states of: CA, GA, IN, MA, MN, MO, NY, OH and PA.
제품 설명
Granada Biphasic Broth || The product is a selective medium for the screening and identification of Streptococcus agalactiae in pregnant women using clinical specimens.