Sona Nanotech Inc C.SONA

RE:this is going to 50 after FDA in 3-7 days

[BadsyBoy56]

hieveverybody wrote:

1. 1. 1. The sample matrix(ces) tested
      2. The technique and collection device(s), including transport media, used to obtain clinical samples All clinical specimens tested in your study should be evaluated in accordance with your proposed diagnostic algorithm, including retesting when appropriate.
      3. The conditions used to collect and store specimens.

 

Please provide the line data in an Excel file as part of the EUA submission for each specimen (please indicate for each specimen if it was prospective, retrospective or contrived and the clinical matrix it represents); the data should include the signal values if applicable and available (for the specimen and the controls) and call/result for your device and, in the case of the natural clinical specimens, the comparator method results should be included.] For clinical specimens collected to support the EUA request, you should adhere to all applicable rules of human subject protection, including IRB approval. 

 

Tests should demonstrate a minimum sensitivity of ≥ 80% for all sample types submitted.

11. UNMET NEED ADDRESSED BY THE PRODUCT 
12.