Lucira COVID-19 All-In-One Test Kit

Lucira’s COVID-19 All-In-One Test Kit is a molecular in vitro diagnostic test that has an analytical sensitivity, or ability to detect the SARS-CoV-2 virus. This test is authorized for prescription home use with self-collected nasal swab samples in individuals aged 14 and older who are suspected of COVID-19 by their healthcare provider. This test is authorized for use in Point of Care settings for individuals aged 14 and older, and in individuals aged 13 and under when the specimen is collected by a healthcare provider. This home test kit has been authorized by FDA under EUA.

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Availability: Commercially Available

Kelly Lewis Brezoczky
Executive Vice President
info@lucirahealth.com
+1 888 582 4724
1412 62nd Street
Emeryville, CA 94608
USA
www.lucirahealth.com
Manufacturer
Lucira Health
Product Name
Lucira COVID-19 All-In-One Test Kit
Detection Category
Biological
Detection Principle
Molecular;
Detection Method
Nucleic Acid Amplification;
Application
Diagnostics;
Equipment Type
Diagnostic
Product Synopsis
Lucira’s COVID-19 All-In-One Test Kit is a molecular in vitro diagnostic test that has an analytical sensitivity, or ability to detect the SARS-CoV-2 virus. This test is authorized for prescription home use with self-collected nasal swab samples in individuals aged 14 and older who are suspected of COVID-19 by their healthcare provider. This test is authorized for use in Point of Care settings for individuals aged 14 and older, and in individuals aged 13 and under when the specimen is collected by a healthcare provider. This home test kit has been authorized by FDA under EUA.
Availability
Commercially Available
Technology Readiness Level (TRL)
9
Market Entry Date
November 2020
User Feedback Sources
Indifferent/No user feedback
No Information Is Available
Transportability
Handheld
Tested For Biological Agents
SARS-CoV-2
Sample Introduction
Biological sample
Response Time (Sample Application To Output)
>15 minutes; 30 minutes
Training Required
<1 hour training
Manuals Available
Yes
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