-- Missing manfuacturer?:

The manufacturer Beckman Coulter, Inc. is not available in the data as can be seen here https://api.fda.gov/device/covid19serology.json?count=manufacturer.exact but it is listed here https://www.fda.gov/medical-devices/emergency-situations-medical-devices/eua-authorized-serology-test-performance

What is the reason that some data appears in openFDA and some does not?

-- Missing tests?:

Also, there are 110 samples for each of the manufacturers, 80 Antibody Truth Negative and 30 Antibody Truth positive. Can you explain this data distribution? It seems that the data that is available under openFDA is hand picked. If so, how/why is it chosen?

1 Answer 1


Unfortunately, we don't have answers to the questions you posted since openFDA merely processes & exposes the COVID data set that we receive via internal FDA channels. We would recommend that you contact the Center for Devices and Radiological Health at FDA directly with your inquiry as they are likely much better suited to answer these. Sorry about the inconvenience.

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