GOBIERNO DE PUERTO RICO

Departamento de Salud
Secretaría Auxiliar para la
Regulación de la Salud Pública
(SARSP)

A. Pruebas caseras de COVID -19 con autorización 510k de FDA

1. Cue Covid-19 Molecular test

2. Flowflex

B. Pruebas caseras para COVID autorizadas mediante permiso de uso de

emergencia (EUA)

1. 3EO Health COVID-19

2. BinaxNOW COVID-19 Ag Card Home Test
3. BinaxNOW COVID-19 Antigen Self Test
4. CareStart COVID-19 Antigen Home Test
5. Advin COVID-19 Antigen Test @Home
6. Metrix COVID-19 Test
7. Fastep COVID-19 Antigen Home Test
8. Azure FaStep® COVID-19 Antigen Pen Home Test
9. Hotgen COVID-19 Antigen Home Test
10. Bio-Self COVID-19 Antigen Home Test
11. Celltrion DiaTrust COVID-19 Ag Home Test
12. CorDx COVID-19 Ag Test
13. ImmuView COVID-19 Antigen Home Test
14. Ellume COVID-19 Home Test
15. Genabio COVID-19 Rapid Self-Test Kit
16. GenBody COVID-19 Ag Home Test
17. iHealth COVID-19 Antigen Rapid Test
18. Swab-N-Go Home Test COVID-19 Ag
19. SCoV-2 Ag Detect Rapid Self-Test
20. MaximBio ClearDetect COVID-19 Antigen Home Test
21. COVI-Go SARS-CoV-2 Ag Self-Test
22. Nano-Check COVID-19 Antigen At-Home Test
23. ASSURE-100 Rapid COVID-19
24. InteliSwab COVID-19 Rapid Test
25. OHC COVID-19 Antigen Self Test
26. Lucira CHECK-IT COVID-19 Test Kit
27. INDICAID COVID-19 Rapid Antigen At-Home Test
28. Status COVID-19 Antigen Rapid Test for Home Use
29. QuickVue At-Home OTC COVID-19 Test
30. Pilot COVID-19 At-Home Test 1
31. OSOM COVID-19 Antigen Home Test
32. CLINITEST Rapid COVID-19 Antigen Self-Test
33. Rapid SARS-CoV-2 Antigen Test Card

1
C. Pruebas combo COVID/Influenza con Permiso de Uso de Emergencia (EUA)

1. OSOM Flu SARS-CoV-2 Combo Home Test

2. Lucira by Pfizer COVID-19 & Flu Home Test

D. Varias pruebas combo/COVID-19 no autorizadas por la FDA

1. TouchBio , RSV, Flu A/B & Covid-19

2. Fanttest Covid-19/Influenza A&B
3. CorDx RSV/ Flu A/B & Covid-19 at home
4. Abingdon Covid – 19/ FLUa A/B Combo test
5. Goldsite SARS-CoV 2& Influenza A/B
6. Fluorecare- Covid-19/FLU A/B /RSV
7. Dvot – SARS-CoV-2 & Influenza A+B
8. Dvot – Covid-19