Guayaquil, 9 de abril de 2020

PRUEBAS RÁPIDAS / REACTIVOS PCR

NÚMERO DE
NOMBRE DEL PRODUCTO NOMBRE DE LA EMPRESA
AUTORIZACIÓN

Severe Acute Respiratory Syndrome

Coronavirus 2 (SARS-CoV-2) IgM/IgG Antibody
Assay Kit by Colloidal Gold Method
8298-DME-0320 MEDEVICES S.A.

SARS-CoV-2 Antibody Test (Lateral Flow

Method)
8287-DME-0320 MEDILABOR S.A.

8390-DME-0420 SARS-COV-2 REALTIME PCR KIT LAB QUALITY S.C.C.

Flash SARS-CoV-2 IgG

8289-DME-0320 IVDTRADING S.A.

FRISONEX FRISON
2019-nCov Ab Test (Colloidal Gold)
IMPORTADORA EXPORTADORA
8299-DME-0320 CIA. LTDA.

COVID-19 IgM/IgG Ab Rapid Test

8342-DME-0420 DIPROSAMEDIC S.A.

VIASURE SARS-CoV-2 Real Time PCR Detection

8373-DME-0420 kit VIBAG C.A.

COVID-19 AB RAPID TEST

CHINA SINOPHARM
8262-DME-0320 INTERNATIONAL CORPORATION
VERI Q PREP M16 VRDNA SWAB / STOOL;
SERUM / PLASMA, GDNA STUTUM, GDNA
BLOOD
8263-DME-0320 MASVIRTUAL S.A.



COVID-19 (SARS-CoV-2) IgM/IgG Antibody Test

Kit MEDICA ECUADOR EQUIPOS E
8261-DME-0320 INSUMOS MEDICOS MEDECU C.A.

2019-nCoV IgG/IgM RapidTest Cassette

8335-DME-0420 DIMPROKEL SA

SARS-COV-2 ANTIBODY TEST (COLLOIDAL GOLD

INMUNOCHROMATOGRAPHY) CINEANGIO SERVICIOS MEDICOS
8337-DME-0420 S.A.

COVID-19 IgG/IgM Test kit

ARIAS URDIALES RODDY
8312-DME-0320 EDUARDO

COVID-19 Rapid Test

8334-DME-0320 MEDIAGNOSTIC S.A.

COVID-19 IgM/IgG Antibody Test (Colloidal IMPORTADORA Y DISTRIBUIDORA

8296-DME-0320 Gold) MEDICA FERBOVASA CIA. LTDA.

Anyplex™ 2019-nCoV Assay

AD16092013 SIMED S. A.

Diagnostic Kit (Colloidal Gold) for IgG/IgM

Antibody to SARS-COV-2
8339-DME-0420 MEDILABOR S.A.

cobas SARS-CoV2
8253-DME-0320 ROCHE ECUADOR S.A.
SARS-CoV-2 IgG and IgM Antibody Combined
Test Kit (Colloidal Gold Chromatographyc
Immunoassay) COVID-19
8341-DME-0420 ESTRELLA SANGO JORGE ARTURO

COVID-19 IgG/IgM Rapid Test Cassette

8302-DME-0320 ALLGENERICOS S.A.

COVID -19 (SARS-CoV-2)IgM/IgG Antibody Test

Kit
8333-DME-0320 VOSCORP S.A.



COVID-19 IgM/IgG Test

8343-DME-0420 RINMED S. A.

COVID-19 IgG/IgM Cassette

8361-DME-0420 VIBAG C.A.

Isopollo® COVID-19 detection kit (real-time)

8375-DME-0420 SALUMED S.A.

EUGENE SARS-CoV2 Rapid Test

8374-DME-0420 SALUMED S.A.

8384-DME-0420 GENEFINDER COVID-19 PLUS REALAMP KIT CEDIMED CIA. LTDA.

SALAS AGUINZACA VICENTE

8382-DME-0420 SARS COVID-19 IgG/IGM Antibody Rapid Test STALIN

SARS-CoV-2 Antibody Test (colloidal gold LAMAN MALDONADO ANGELA

8385-DME-0420 immunochromatography) DAYANA

Xpert® Xpress SARS-CoV-2

SISTEMAS DE SALUD
8340-DME-0420 ROCARSYSTEM S.A.

8366-DME-0420 COVID-19 Rapid Tests IRPLUS S.A.

SARS-CoV-2 IgG/IgM Test Cassette (Whole

Blood/Serum/Plasma) ONE STEP RAPID TEST
8354-DME-0420 IRISGLOBAL ECUADOR CIA. LTDA.

Diagnostic Kit (Colloidal Gold）for

8378-DME-0420 IgG/IgMAntibody to Covid-19 GTIHEALTH S.A.

8363-DME-0420 2019-nCoV IgG / IgM ANTIBODY ASSAY KIT VIVE-CHINA CIA.LTDA.



FilmArray Respiratory Panel 2 plus

744-RBE-0116 SIMED S. A.

GAVILANEZ BUENAÑO TRAJANO

8370-DME-0420 COVID-19 IgG/IgM Rapid Test Device(WB/S/P) RUPERTO

8383-DME-0420 COVID-19 ANTIBODY IgG/IgM Rapid Test DEVICE IDELIFE CIA. LTDA.

DAVILA ANDALUZ CESAR

8336-DME-0420 COVID-19 IgM/IgG Ab Rapid Test HOMERO

8386-DME-0420 SARS -COV-2 Antibody Test GEDEONRICHTER ECUADOR SA

8362-DME-0420 2019-nCOV IgG/IgM RAPID TEST DEVICE COFEKA CIA. LTDA.

GAVILANEZ BUENAÑO TRAJANO

8370-DME-0420 COVID-19 IgG/IgM Rapid Test Device(WB/S/P) RUPERTO

ONE STEP TEST KIT FOR NOVEL CORANAVIRUS ( ARAUJO GALLEGOS JOHANNA
8352-DME-0420 2019 O COV) IGM/IGG ANTIBODY CAROLINA

PruebaRápida deCOVID-19 ARIAS POLANCO ANDREA

8392-DME-0420 IgG/IgM(SangreEntera/Suero/Plasma) Cassette CAROLINA

8404-DME-0420 Kit de Diagnostico de COVID-19 IgG/IgM ECUAPROFARM CIA. LTDA.

TEJADA ERAZO MICHAEL

8405-DME-0420 COVID-19 IgG/IgM Rapid Test Kit ALEJANDRO




SARS-CoV-2 IgG/IgM antibody Rapid Qualitative

Test Kit (colloidal gold method) / SARS-CoV-2
lgM antibody Rapid Qualitative Test Kit
8398-DME-0420 (colloidal gold method) XIMPA S.C.P.

PHONTECALLING S.A.
8402-DME-0420 Coronavirus Disease 2019 (COVID-19) RT-PCR PHONTECALLING

COVID-19 IgM/IgG Rapid Test (Colloidal Gold

8409-DME-0420 Inmuno-Chromatography) LIFEPRO WATER LPW SA