Florida Department of Health Emergency Rule 64DER21-12 provides opportunities for public school students to reduce quarantine or
isolation if they are asymptomatic and receive a negative diagnostic test for COVID-19.1 If a public school student is using one of the
opportunities, as described in Emergency Rule 64DER21-12, to obtain a diagnostic COVID-19 test result to shorten their isolation or
quarantine period, the COVID-19 diagnostic test should have received Emergency Use Authorization (EUA) from, or full approval by,
the Food and Drug Administration (FDA) and the COVID-19 test should be used in the same manner specified by FDA’s
authorization or approval. The table below lists current COVID-19 diagnostic tests that have received an EUA by the FDA and how
they can (i.e., over the counter or at-home) and should (i.e., symptomatic and/or asymptomatic) be used.
COVID-19 Tests that have received EUA from the FDA
2
Antigen Tests Symptomatic Asymptomatic Over the Counter Tests Prescription At-Home
Use Use3 Tests
Ellume COVID-19 Home Test X X X
BinaxNOW COVID-19 Ag Card 2 Home Test X X
QuickVue At-Home OTC COVID-19 Test X X
BinaxNOW COVID-19 Antigen Self Test X X
InteliSwab COVID-19 Rapid Test X X
CareStart COVID-19 Antigen Home Test X X
InteliSwab COVID-19 Rapid Test Rx X X
BinaxNOW COVID-19 Ag Card Home Test X X
QuickVue At-Home COVID-19 Test X X
InteliSwab COVID-19 Rapid Test Pro X
BinaxNOW COVID-19 Ag Card X
BinaxNOW COVID-19 Ag 2 Card X
CareStart COVID-19 Antigen X
BD Veritor System for Rapid Detection of X
SARS-CoV-2
BD Veritor System for Rapid Detection of X
SARS-CoV-2 & Flu A&B
Sampinute COVID-19 Antigen MIA X
LIAISON SARS-CoV-2 Ag X
1
https://www.flgov.com/wp-content/uploads/2021/08/8.6.21-DOH-Rule.pdf
2
https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2
3
These tests have been approved for “Screening” and can be used for asymptomatic testing; this is not to be confused with “Serial Screening.”
August 19, 2021 1
ellume.lab COVID Antigen Test X
GenBody COVID-19 Ag X
SCoV-2 Ag Detect Rapid Test X
CLIP COVID Rapid Antigen Test X
LumiraDX SARS-CoV-2 Ag Test X
VITROS Immunodiagnostic Products X
INDICAID COVID-19 Rapid Antigen Test X
Status COVID-10/Flu X
QIAreach SARS-CoV-2 Antigen X
Omnia SARS-CoV-2 Antigen Test X
Simoa SARS-CoV-2 N Protein Antigen Test X
Sofia SARS Antigen FIA X
Sofia 2 Flu + SARS Antigen FIA X
QuickVue SARS Antigen Test X
Sienna-Clarify COVID-19 Antigen Test Rapid X
Test Cassette
Molecular Tests4
Any PCR Test given by provider or sent to a X X
commercial laboratory5
Lucira CHECK-IT COVID-19 Test Kit X X X
Cue COVID-19 Test for Home and Over the X X X
Counter (OTC) Use
Lucira COVID-19 All-In-One Test Kit X X X
Everly COVID-19 Test Home Collection Kit X X X
Direct to Consumer
Kroger Health COVID-19 Test Home Collection X X X
Kit
Color COVID-19 Self-Swab Collection Kit X X X
4
https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-molecular-diagnostic-tests-sars-
cov-2
5
Includes “Direct to Consumer” and “Home Collection” tests, as these tests are sent to a commercial laboratory.
August 19, 2021 2
EmpowerDX COVID-19 Home Collection Kit X X X
Direct to Consumer
binx health At-Home Nasal Swab Collection Kit X X X
GetMyDNA COVID-19 Test Home Collection X X X
Kit
Pinpoint by Phosphorus COVID-19 Test Home X X X
Collection Kit DTC
WREN Laboratories COVID-19 Saliva Test X X X
Collection Kit DTC
August 19, 2021 3
