The first kits will be sent to chain pharmacies th
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Posted On: 03/22/2020 11:10:53 AM
Re: DirkEaston #9260
The first kits will be sent to chain pharmacies that operate in store clinics (Walgreens, CVS and Walmart), private commercial laboratories that have remote blood drawing stations, home health agencies that visit patients in their homes, long term care facilities, and hospital outpatient clinics. Everyone with a stand-alone kit follows this soft requirement. That is, everyone saying they have a kit will follow. Those methods that employ swabs have to follow since the swabs are only read by instruments at hospitals and commercial laboratories.
The FDA EUA was written for the SARS epidemic and still has a requirement that the maker of the diagnostic also be the administrator of the diagnostic. For SARS-CV this has been changed a little to include administration by professionals and semi-professionals -- those people who give shots and draw blood.
I am so totally confused. Certainly THE consultant to the industry would know this.
The FDA EUA was written for the SARS epidemic and still has a requirement that the maker of the diagnostic also be the administrator of the diagnostic. For SARS-CV this has been changed a little to include administration by professionals and semi-professionals -- those people who give shots and draw blood.
I am so totally confused. Certainly THE consultant to the industry would know this.
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