Guayaquil, 20 de abril de 2020

PRUEBAS RÁPIDAS

NÚMERO DE NOMBRE DEL PRODUCTO NOMBRE DE LA NOMBRE DEL

AUTORIZACIÓN EMPRESA TITULAR DEL
PRODUCTO
8298-DME-0320 REACTIVOS/KITS PARA MEDEVICES S.A. MACCURA
ENSAYOS DIV, ENSAYO BIOTECHNOLOGY
MOLECULAR,INFECCION,VIR CO.,LTD.
US,CORONAVIRUS DEL
SINDROME RESPIRATORIO
AGUDO SEVERO,RNA
8287-DME-0320 SARS-CoV-2 Antibody Test MEDILABOR S.A.
(Lateral Flow Method) GUANGZHOU
WONDFO
BIOTECH CO.,
LTD.

8289-DME-0320 Flash SARS-CoV-2 IgG IVDTRADING S.A. SHENZHEN YHLO
BIOTECH CO., LTD.

8299-DME-0320 2019-nCov Ab Test FRISONEX FRISON

(Colloidal Gold) IMPORTADORA INNOVITA
EXPORTADORA CIA. (TANGSHAN)
LTDA. BIOLOGICAL
TECHNOLOGY CO.,
LTD.

8342-DME-0420 COVID-19 IgM/IgG Ab DIPROSAMEDIC S.A. QINGDAO
Rapid Test HIGHTOP BIOTECH
CO., LTD

8262-DME-0320 COVID-19 AB RAPID TEST CHINA SINOPHARM QUINGDAO
INTERNATIONAL HIGHTOP BIOTECH
CORPORATION CO. LTD








8261-DME-0320 COVID-19 (SARS-CoV-2) MEDICA ECUADOR ANHUI DEEPBLUE
IgM/IgG Antibody Test Kit EQUIPOS E MEDICAL
INSUMOS MEDICOS TECHNOLOGY
MEDECU C.A. CO.LTD

4009-DME-0518 IVD Test Reagents/Kits, LAB QUALITY S.C.C. ACRO BIOTECH,
Prueba rapida, Virus, INC.

8335-DME-0420 2019-nCoV IgG/IgM DIMPROKEL SA VENCO M&P CA

RapidTest Cassette

8337-DME-0420 SARS-COV-2 ANTIBODY CINEANGIO

TEST (COLLOIDAL GOLD SERVICIOS LEPU MEDICAL
INMUNOCHROMATOGRAP MEDICOS S.A. TECHNOLOGY(BEIJ
HY) ING) CO., LTD

8312-DME-0320 COVID-19 IgG/IgM Test kit ARIAS URDIALES HANGZHOU
RODDY EDUARDO SINGCLEAN
MEDICAL
PRODUCTS CO.,
LTD.

8334-DME-0320 COVID-19 Rapid Test MEDIAGNOSTIC BIOMERICA, INC
S.A.

8296-DME-0320 COVID-19 IgM/IgG Antibody IMPORTADORA Y PROMOTORA SN

Test (Colloidal Gold) DISTRIBUIDORA SAI DE CV (ZOGEN)
MEDICA
FERBOVASA CIA.
LTDA.
AD16092013 Anyplex™ 2019-nCoV Assay SIMED S. A. SEEGENE INC.

8339-DME-0420 Diagnostic Kit (Colloidal MEDILABOR S.A. XIAMEN WIZ

Gold) for IgG/IgM Antibody BIOTECH CO.,LTD.
to SARS-COV-2

8253-DME-0320 cobas SARS-CoV2 ROCHE ECUADOR ROCHE
S.A. MOLECULAR
SYSTEMS INC

8302-DME-0320 COVID-19 IgG/IgM Rapid ALLGENERICOS S.A. AMERICAN BIO
Test Cassette MEDICA
CORPORATION

8333-DME-0320 COVID -19 (SARS-CoV- VOSCORP S.A. ANHUI DEEPBLUE
2)IgM/IgG Antibody Test Kit MEDICAL
TECHNOLOGY
CO.LTD

8343-DME-0420 COVID-19 IgM/IgG Test RINMED S. A. SHENZHEN
RENDER BIOTECH
CO., LTD.,

8361-DME-0420 COVID-19 IgG/IgM Cassette VIBAG C.A. LINEAR
CHEMICALS, S.L.U

8374-DME-0420 EUGENE SARS-CoV2 Rapid SALUMED S.A. SHANGHAI

Test EUGENE BIOTECH
CO.,LTD.

8384-DME-0420 GENEFINDER COVID-19 CEDIMED CIA. OSANG
PLUS REALAMP KIT LTDA. HEALTHCARE CO.
LTD.

8413-DME-0420 Anti-SARS-CoV-2 Rapid Test REACTLAB IMPORT AUTOBIO
CIA. LTDA DIAGNOSTICS CO.,
LTD.

8382-DME-0420 SARS COVID-19 IgG/IGM SALAS AGUINZACA QINGDAO
Antibody Rapid Test VICENTE STALIN HIGHTOP BIOTECH
CO.,LTD.

8385-DME-0420 SARS-CoV-2 Antibody Test LAMAN BEIJING LEPU
(colloidal gold MALDONADO MEDICAL
immunochromatography) ANGELA DAYANA TECHONOLOGY
CO., LTD








8340-DME-0420 Xpert® Xpress SARS-CoV-2 SISTEMAS DE CEPHEID
SALUD
ROCARSYSTEM S.A.
8366-DME-0420 COVID-19 Rapid Tests IRPLUS S.A. IR DISTRIBUTION
LLC

8416-DME-0420 COVID-19 cassettes ANDRADE PAULA INFINITE GROUP

IgM&IgG Rapid Test Kit SANTIAGO ASIA, CO.LTD.
ALEJANDRO

8354-DME-0420 SARS-CoV-2 IgG/IgM Test IRISGLOBAL TRISTONE

Cassette (Whole ECUADOR CIA. TECHNOLOGY
Blood/Serum/Plasma) ONE LTDA. HANGZHOU CO.,
STEP RAPID TEST LTD.

8404-DME-0420 Kit de Diagnostico de ECUAPROFARM ZHEJIANG ORIENT
COVID-19 IgG/IgM CIA. LTDA. GENE BIOTECH
CO., LTD

8378-DME-0420 Diagnostic Kit (Colloidal GTIHEALTH S.A. XIAMEN WIZ
Gold）for IgG/IgMAntibody BIOTECH CO., LTD
to Covid-19

8405-DME-0420 COVID-19 IgG/IgM Rapid TEJADA ERAZO NANTONG EGENS

Test Kit MICHAEL BIOTECHNOLOGY
ALEJANDRO CO., LTD.

8363-DME-0420 2019-nCoV IgG / IgM VIVE-CHINA BEIJING DIAGREAT
ANTIBODY ASSAY KIT CIA.LTDA. BIOTECHNOLOGY
CO., LTD

8424-DME-0420 Prueba de anticuerpos SAR- FARMABION DEL GUANGZHOU
CoV-2 (método de flujo ECUADOR C.A. WONDFO BIOTECH
lateral) CO., LTD.

8370-DME-0420 COVID-19 IgG/IgM Rapid GAVILANEZ SAFECARE
Test Device(WB/S/P) BUENAÑO BIOTECH
TRAJANO RUPERTO (HANGZHOU) CO
LTD

8383-DME-0420 COVID-19 ANTIBODY IDELIFE CIA. LTDA. SAFECARE
IgG/IgM Rapid Test DEVICE BIOTECH
(HANGZHOU) CO.,
LTD.




8336-DME-0420 COVID-19 IgM/IgG Ab Rapid DAVILA ANDALUZ QINGDAO
Test CESAR HOMERO HIGHTOP BIOTECH
CO. LTD.

8386-DME-0420 SARS -COV-2 Antibody Test GEDEONRICHTER GUANGZHOU
ECUADOR SA WONDFO BIOTECH
CO., LTD.

8414-DME-0420 COVID-19 IgG/IgM Rapid DISTRIBUIDORA NANTONG EGENS
Test Kit (Colloidal Gold) FARMATODO S.A. BIOTECHNOLOGY
CO.,LTD.

8362-DME-0420 2019-nCOV IgG/IgM RAPID COFEKA CIA. LTDA. HANGZHOU REALY
TEST DEVICE TECH CO., LTD.

8425-DME-0420 TEST RÁPIDO DE GOMEZ NARANJO MEDICAL SYSTEM

DETECCIÓN DE COVID 2019 JHONATHAN BIOTECHNOLOGY
(IgM/IgG) ALEXANDER CO., LTD

8398-DME-0420 SARS-CoV-2 IgG/IgM XIMPA S.C.P. SIN FRONTERAS
antibody Rapid Qualitative MEDICAL SUPPLIES
Test Kit (colloidal gold LLC
method)
8418-DME-0420 COVID-19 (SARS-CoV-2) COTEMAC S.A. WUHAN
Nucleic Acid Test Kit EASYDIAGNOSIS
BIOMEDICINE CO.,
LDT.

8392-DME-0420 PruebaRápida deCOVID-19 ARIAS POLANCO HANGZHOU
IgG/IgM(SangreEntera/Suer ANDREA CAROLINA BIOTEST BIOTECH
o/Plasma) Cassette CO., LTD

8352-DME-0420 ONE STEP TEST KIT FOR ARAUJO GALLEGOS JIANGSU
NOVEL CORANAVIRUS ( JOHANNA KONSUNG BIO-
2019 O COV) IGM/IGG CAROLINA MEDICAL SCIENCE
ANTIBODY AND TECHNOLOGY
CO., LTD.

8409-DME-0420 COVID-19 IgM/IgG Rapid LIFEPRO WATER W.H.P.M., INC.
Test (Colloidal Gold LPW SA
Inmuno-Chromatography)






5367-DME-0818 MAGLUMI 2019-nCoV IgG RAPIDIAGNOSTICS SHENZHEN NEW
(CLIA)// MAGLUMI 2019- S.A. LNDUSTRIES
nCoV IgM (CLIA) BIOMEDICAL
ENGINEERING CO.,
LTD.

8431-DME-0420 2019-nCoV IgG-IgM Rapid SUMINISTROS ACRO BIOTECH
Test MEDICOS INC
MANOSALVAS
VILLAGOMEZ MV
ASOCIADOS CIA.
LTDA.
8427-DME-0420 Coronavirus Disease 2019 HERNANDEZ MEDICALSYSTEM
Antibody (IgM/IgG) NUÑEZ SERVICIOS Y BIOTECHNOLOGY
Combined Test Kit SOLUCIONES CO., LTD.
MEDICAS CIA.
LTDA.
8444-DME-0420 VivaDiag TM COVID-19 PRODONTOMED VIVACHECK
IgM/IgG Rapid Test S.A. BIOTECH

8449-DME-0420 COVID-19 IgG/IgM Rapid OSMATOUR S.A. HANGZHOU

Test CLONGENE BIOTEC
CO. LTDA.

8442-DME-0420 COVID-19 IgM-IgG Rapid ECZANE PHARMA BIOMEDOMICS
Test LABORATORIOS INC
ECZANEPHARMA SA
8436-DME-0420 SARS CoV-2 (COVID-19) REPRESENTACIONE HANGZHOU TEST
IgG/IgM test S INDUSTRIALES SEA
REINDUSTRIAL CIA. BIOTECHNOLOGY
LTDA. CO., LTD

8447-DME-0420 COVID-19 IgG/IgM rapid AEV ECUADORIAN ASSURE TECH
test SHIPPING AEVSHIP (HANGZHUO) CO.,
S.A. LTD

8284-DME-0320 COVID-19 AG RESPI- BENALCAZAR CORIS
STRIP/COVID-19 AG RESPI- NEGRETE SANDRA BIOCONCEPT
STRIP PATRICIA

8460-DME-0420 2019-nCOV IgG/IgM Rapid PEÑA ESPIN PENA ESPIN

Test Device DANIELA ELIZABETH DANIELA
ELIZABETH




8461-DME-0420 COVID – 19 IgM / IgG TEST ALESSA S.A. SAFECARE
BIOTECH(HANGZH
OU)CO.,LTD.

8458-DME-0420 COVID 19 IgG/IgM Rapid BURGOS PUERTAS HANGZHOU
Test kit SEBASTIAN CLONGENE
BIOTECH CO.,LTD.

8459-DME-0420 SARS-CoV-2 IgM Antibody IMPORTADORA Y BEIJING LEPU
Test (colloidal gold DISTRIBUIDORA DE MEDICAL
immunochromatography) INSUMOS MEDICOS TECHNOLOGY CO.,
IDIMSA S.A. LTD.

8457-DME-0420 Diagnostic Kit for IgM/IgG SOLUCIONES ZHUHAI LIVZON
Antibody to Coronavirus INTEGRALES DIAGNOSTICS INC
(SAR S-CoV-2) (Lateral Flow) HOSPITALARIAS
10 Test Sets/Kit//(SAR S- SOLINHOS CIA.
CoV-2) (Lateral Flow) LTDA.
20 Test Sets/Kit
8461-DME-0420 COVID – 19 IgM / IgG TEST ESTUARDO ALCIDES SAFECARE
SANCHEZ GARCIA BIOTECH(HANGZH
OU)CO.,LTD.

8451-DME-0420 COVID-19 IgG/IgM RAPID BENALCAZAR SHENZHEN
TEST KIT NEGRETE SANDRA REAGENT
PATRICIA TECHNOLOGY CO.,
LTD

8471-DME-0420 COVID-19 IgG/IgM test GENELEKTA S.A. GENBODY INC
rapid immunoassay for
COVID-19 infection
8489-DME-0420 Anti-SARS-CoV-2 Rapid Test RECOR DENTAL Y AUTOBIO
QUIMEDIC S.A. DIAGNOSTICS
CO.,LTD

8485-DME-0420 COVID-19 REACTLAB IMPORT HANGZHOU
CIA. LTDA BIOTEST BIOTECH
CO., LTD


8500-DME-0420 Humasis COVID-19 IgG/IgM LAB QUALITY S.C.C. HUMASIS CO., LTD
Test

8499-DME-0420 COVID-19 IgG/IgM RAPID A INTERNATIONAL QINGDAO
TEST DEVICE (WHOLE ECUADOR HIGHTOP BIOTECH
BLOOD/SERUM/PLASMA) AINTERECUSA S.A. CO., LTD.

8488-DME-0420 SARS-COV2 IGM/IGG PAZMIÑO NARVAEZ QINGDAO
ANTIBODY RAPID TEST PABLO GREGORIO HIGHTOP BIOTECH
CO.. LTDA




Actualmente la Organización Mundial de la Salud (OMS) recomienda la
implementación del protocolo de detección molecular para 2019-nCoV. RT-PCR en
tiempo real y señala una serie de limitaciones del uso de test de detección de
anticuerpos IgM e IgG, por lo que no son considerados como un test apropiado para la
confirmación o diagnóstico de casos de SARS-CoV-2. La detección de anticuerpos IgM
e IgG puede apoyar en investigaciones epidemiológicas, estudios de brotes o estudios
de seroprevalencia.