Lab POL Guide - 2023 - 1E

Covid-19 At-Home Testing
Flowflex™
COVID-19 Antigen Home Test*
Tests for the qualitative detection of the nucleocapsid protein antigen from
SARS-CoV-2 in anterior nasal swab specimens directly from individuals within
7 days of symptom onset, or without symptoms or other epidemiological
reasons to suspect COVID-19 infection. This test has been authorized for nonprescription
use with self-collected specimens from individuals age 14 and older
or with adult collected specimens from individuals 2 years or older. One test only
required. No serial testing needed.
#L031-118B5
(141-4132).............................................................................10/box
*This product has not been FDA cleared or approved; but has been authorized by the FDA under an EUA.
This product has been authorized only for the detection of proteins from SARS- CoV-2, not for any other viruses or pathogens.
The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under
Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
CLINITEST®
Rapid COVID-19 Antigen Self-Test*
Uses a simple nasal swab to provide accurate COVID-19 test results (including for the Omicron
and Delta variants) in 15 minutes, and it comes packaged 5 tests per box, making it convenient
for families, groups, and serial testing needs.
* OTC (nonprescription)
* Qualitative results in 15 minutes are visually interpreted: no instrument required
* 85.4% sensitivity (PPA), 99.3% specificity (NPA)
* Authorized for use with self-collected anterior nasal swabs by individuals ages 14+
or adult-collected samples from individuals ages 2-13
* For use by individuals with symptoms of COVID-19 within the first 7 days of symptom onset
when tested at least twice over three days with at least 48 hours between tests, and for
individuals without symptoms or other epidemiological reasons to suspect COVID-19, when
tested at least three times over five days with at least 48 hours between tests
* Nasal swab samples
* 5 tests/box option available for U.S. market initially
* Store at room temperature or can be refrigerated
* 11-month shelf life (from date of original manufacturing)
22MS9092
1e
#11556711
(141-5304)...................................................... 5/pkg
Contains: 5 of each: test devices, sterile swabs, extraction
tubes with buffers and tips; & 1 of each: tube holder &
instructions for use.
* This product has not been FDA cleared or approved, but has been
authorized by FDA under an EUA;
*This product has been authorized only for the detection of proteins from
SARS[1]CoV-2, not for any other viruses or pathogens; and
*The emergency use of this product is only authorized for the duration
of the declaration that circumstances exist justifying the authorization
of emergency use of in vitro diagnostics for detection and/or diagnosis
of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and
Cosmetic Act, 21 U.S.C. § 360bbb[1]3(b)(1), unless the declaration is
terminated or authorization is revoked sooner
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Lab POL Guide - 2023

Table of Contents for the Digital Edition of Lab POL Guide - 2023