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Posted On: 03/23/2021 3:57:53 PM
Post# of 22461
Appears the FDA has authorized the first Covid-19 home test, by Tempus Labs, Inc. Test determined by their healthcare provider:
"Authorized Product Details
Your product is a qualitative test for the detection of nucleic acid from SARS-CoV-2 in NP, AN,
mid-turbinate nasal, and OP swab specimens collected from individuals suspected of COVID-19 by their healthcare provider. Your product is also for use with AN swab specimens that are self-collected unsupervised at home by individuals 18 years of age or older using the Tempus Nasal Sample Collection Kit, when determined to be appropriate by their healthcare provider."
https://www.fda.gov/media/142593/download
"Authorized Product Details
Your product is a qualitative test for the detection of nucleic acid from SARS-CoV-2 in NP, AN,
mid-turbinate nasal, and OP swab specimens collected from individuals suspected of COVID-19 by their healthcare provider. Your product is also for use with AN swab specimens that are self-collected unsupervised at home by individuals 18 years of age or older using the Tempus Nasal Sample Collection Kit, when determined to be appropriate by their healthcare provider."
https://www.fda.gov/media/142593/download
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