HEMAGEN DIAGNOSTICS INC.: Brazil (ANVISA) registrations and registration holders

Product	Device type	Class	Holder	Published	Status
ANTICORPO ANTI-MUSCULO LISO E ANTICORPO DECELULA PARIETAL VIRGO 10322610054	Combined parameters in one product - class II	II	KIMENZ EQUIPAMENTOS LTDA	01/07/2019	Valid
ANTI-DNA ENZIMAIMUNOENSAIO 10322610028	Antinuclear antibody (ANA)	II	KIMENZ EQUIPAMENTOS LTDA	08/04/2019	Valid
ANA/HEp-2 IgG (ANTICORPOS ANTINUCLEARES IgG) IMUNOFLUORESCENCIA 10322610029	Antinuclear antibody (ANA)	II	KIMENZ EQUIPAMENTOS LTDA	08/04/2019	Valid
ANTICORPO CITOPLASMATICO ANTI NEUTROFILO (C-ANCA)VIRGO 10322610033	Anti-cytoplasmic antibody	II	KIMENZ EQUIPAMENTOS LTDA	08/04/2019	Valid
ANTICORPOS ANTI-MITOCONDRIA (AMA) IgG IMUNOFLUORESCENCIA 10322610034	Antimitochondrial antibody	II	KIMENZ EQUIPAMENTOS LTDA	08/04/2019	Valid
VARICELLA ZOSTER IgG IMUNOFLUORESCÊNCIA 10322610037	Herpesvirus (HHV-3) - varicella-zoster	III	KIMENZ EQUIPAMENTOS LTDA	08/04/2019	Until 25/10/2026
TESTE DE PESQUISA DE AUTOIMUNE PAINEL 2 VIRGO 10322610038	Combined parameters in one product - class II	II	KIMENZ EQUIPAMENTOS LTDA	08/04/2019	Valid
SM-EIA 10322610039	Anti-extractable nuclear antigen (ENA) antibody	II	KIMENZ EQUIPAMENTOS LTDA	08/04/2019	Valid
SM/RNP-EIA 10322610040	Anti-extractable nuclear antigen (ENA) antibody	II	KIMENZ EQUIPAMENTOS LTDA	08/04/2019	Valid
SS-B (La) - EIA 10322610041	Anti-extractable nuclear antigen (ENA) antibody	II	KIMENZ EQUIPAMENTOS LTDA	08/04/2019	Valid
SS-A (RO)-EIA 10322610042	Anti-extractable nuclear antigen (ENA) antibody	II	KIMENZ EQUIPAMENTOS LTDA	08/04/2019	Valid
RSV IgG (VIRUS RESPIRATORIO SINCICIAL)IMUNOFLUORESCENCIA 10322610043	Respiratory syncytial virus (RSV)	II	KIMENZ EQUIPAMENTOS LTDA	08/04/2019	Valid
JO-1-EIA 10322610045	Anti-extractable nuclear antigen (ENA) antibody	II	KIMENZ EQUIPAMENTOS LTDA	08/04/2019	Valid
ENA SCREENING 6 EIA 10322610047	Anti-extractable nuclear antigen (ENA) antibody	II	KIMENZ EQUIPAMENTOS LTDA	08/04/2019	Valid
Controle de anti-Endomísio IgG 10322610048	Celiac disease antibody	II	KIMENZ EQUIPAMENTOS LTDA	08/04/2019	Valid
CONJUGADO IgG anti- ENDOMÍSIO 10322610049	Immunoglobulin G	II	KIMENZ EQUIPAMENTOS LTDA	08/04/2019	Valid
CONJUGADO UNIVERSAL IgM 10322610050	Immunoglobulin M	II	KIMENZ EQUIPAMENTOS LTDA	08/04/2019	Valid
CAXUMBA (MUMPS) IgG IMUNOFLUORESCENCIA 10322610051	Mumps virus	II	KIMENZ EQUIPAMENTOS LTDA	08/04/2019	Valid
Scl-70 EIA 10322610053	Anti-extractable nuclear antigen (ENA) antibody	II	KIMENZ EQUIPAMENTOS LTDA	08/04/2019	Valid
Anticardiolipina GM- ELISA-Kit Jumbo 10280220197	Anticardiolipin	II	HEMAGEN DIAGNOSTICOS COMERCIO IMP E EXPORTACAO LTDA	22/11/2010	Valid
JO-1 HEMAGLUTINACAO 10280220152	Anti-extractable nuclear antigen (ENA) antibody	II	HEMAGEN DIAGNOSTICOS COMERCIO IMP E EXPORTACAO LTDA	09/08/2001	Valid
DNA HEMAGLUTINACAO 10280220153	Anti-extractable nuclear antigen (ENA) antibody	II	HEMAGEN DIAGNOSTICOS COMERCIO IMP E EXPORTACAO LTDA	09/08/2001	Valid
RF (FATOR REUMATOIDE) HEMAGLUTINACAO 10280220156	Rheumatoid factor	II	HEMAGEN DIAGNOSTICOS COMERCIO IMP E EXPORTACAO LTDA	09/08/2001	Valid
RNP/Sm HEMAGLUTINACAO 10280220158	Anti-extractable nuclear antigen (ENA) antibody	II	HEMAGEN DIAGNOSTICOS COMERCIO IMP E EXPORTACAO LTDA	09/08/2001	Valid
SS-A/SS-B-HEMAGLUTINACAO 10280220160	Anti-extractable nuclear antigen (ENA) antibody	II	HEMAGEN DIAGNOSTICOS COMERCIO IMP E EXPORTACAO LTDA	09/08/2001	Valid
ScI/70 HEMAGLUTINACAO 10280220161	Anti-extractable nuclear antigen (ENA) antibody	II	HEMAGEN DIAGNOSTICOS COMERCIO IMP E EXPORTACAO LTDA	09/08/2001	Valid
ENA SCREENING 4 HEMAGLUTINACAO 10280220165	Anti-extractable nuclear antigen (ENA) antibody	II	HEMAGEN DIAGNOSTICOS COMERCIO IMP E EXPORTACAO LTDA	09/08/2001	Valid

HEMAGEN DIAGNOSTICS INC.

Brazilian registration holders

Device types

Registrations