MBIOLOG DIAGNOSTICOS LTDA: Brazil (ANVISA) registrations and registration holders

Product	Device type	Class	Holder	Published	Status
IMUNOSCREEN SÍFILIS TOTAL DBS 80047580230	Treponema pallidum total antibodies	IV	MBIOLOG DIAGNÓSTICOS LTDA	15/06/2026	Until 15/06/2036
IMUNOSCREEN CMV IGG DBS 80047580229	Cytomegalovirus (CMV) IgG	IV	MBIOLOG DIAGNÓSTICOS LTDA	18/02/2026	Until 18/02/2036
IMUNOSCREEN TOXOPLASMOSE IGG DBS 80047580228	Toxoplasma gondii IgG	IV	MBIOLOG DIAGNÓSTICOS LTDA	14/07/2025	Until 14/07/2035
IMUNOSCREEN CMV IGM DBS 80047580227	Cytomegalovirus (CMV) IgM	IV	MBIOLOG DIAGNÓSTICOS LTDA	07/07/2025	Until 07/07/2035
IMUNOSCREEN RUBÉOLA IGM DBS 80047580226	Rubella virus	III	MBIOLOG DIAGNÓSTICOS LTDA	19/05/2025	Until 19/05/2035
IMUNOSCREEN NEO TSH DBS 80047580224	Thyroid-stimulating hormone (TSH) - newborn screening	III	MBIOLOG DIAGNÓSTICOS LTDA	28/04/2025	Until 28/04/2035
IMUNOSCREEN NEO IRT DBS 80047580225	Immunoreactive trypsin (IRT) - newborn screening	III	MBIOLOG DIAGNÓSTICOS LTDA	28/04/2025	Until 28/04/2035
IMUNOSCREEN CHAGAS DBS 80047580223	Trypanosoma cruzi IgG	IV	MBIOLOG DIAGNÓSTICOS LTDA	04/11/2024	Until 04/11/2034
FAMÍLIA MEIOS DE CULTURA SELETIVOS MBIO 80047580221	Selective culture media for specific groups of microorganisms	I	MBIOLOG DIAGNÓSTICOS LTDA	08/07/2024	Valid
FAMÍLIA MEIO DE CULTURA DE SEMEADURA PRIMÁRIA MBIO 80047580222	Culture media and devices for primary inoculation only	I	MBIOLOG DIAGNÓSTICOS LTDA	08/07/2024	Valid
IMUNOSCREEN NEO 17-OHP DBS 80047580220	17-Hydroxyprogesterone (17-OHP) - newborn screening	III	MBIOLOG DIAGNÓSTICOS LTDA	14/02/2024	Until 14/02/2034
FAMÍLIA MEIO DE CULTURA ÁGAR CROMOGÊNICO MBIO 80047580219	Differential culture media and devices for biochemical identification of microorganisms	I	MBIOLOG DIAGNÓSTICOS LTDA	23/10/2023	Valid
IMUNOSCREEN NEO PKU - SS 80047580218	Amino acids - newborn screening	III	MBIOLOG DIAGNÓSTICOS LTDA	11/09/2023	Until 11/09/2033
IMUNOSCREEN TOXO IGM DBS 80047580217	Toxoplasma gondii IgM	IV	MBIOLOG DIAGNÓSTICOS LTDA	02/05/2023	Until 02/05/2033
TSH ELISA 80047580215	Thyroid-stimulating hormone (TSH)	II	MBIOLOG DIAGNÓSTICOS LTDA	27/03/2023	Valid
T4 TOTAL ELISA 80047580216	Thyroxine (T4)	II	MBIOLOG DIAGNÓSTICOS LTDA	27/03/2023	Valid
IMUNOCROM MB SANGUE OCULTO 80047580212	Fecal occult blood	III	MBIOLOG DIAGNÓSTICOS LTDA	07/02/2022	Until 07/02/2032
Dímero D Turb Cepa 80047580211	D-dimer	III	MBIOLOG DIAGNÓSTICOS LTDA	31/01/2022	Until 31/01/2032
ALLSERUM EIA COVID-19 AC TOTAIS 80047580210	Coronavirus	III	MBIOLOG DIAGNÓSTICOS LTDA	20/09/2021	Until 20/09/2031
IMUNOSCREEN ANTI-HBc SS 80047580208	Total antibody to hepatitis B core antigen (anti-HBc)	IV	MBIOLOG DIAGNÓSTICOS LTDA	23/08/2021	Until 23/08/2031
ALLSERUM EIA SARS-COV-2 IGG 80047580206	Coronavirus	III	MBIOLOG DIAGNÓSTICOS LTDA	21/06/2021	Until 21/06/2031
ALLSERUM EIA SARS-COV-2 IGM 80047580207	Coronavirus	III	MBIOLOG DIAGNÓSTICOS LTDA	21/06/2021	Until 21/06/2031
Mueller Hinton + Sangue MH-F 80047580204	Culture media and devices for antimicrobial susceptibility testing	II	MBIOLOG DIAGNÓSTICOS LTDA	25/02/2021	Valid
ALLSERUM DENGUE IGG 80047580203	Dengue	III	MBIOLOG DIAGNÓSTICOS LTDA	08/02/2021	Until 08/02/2031
ALLSERUM EIA Covid-19 IgG Dried Blood Spot 80047580202	Coronavirus	III	MBIOLOG DIAGNÓSTICOS LTDA	22/06/2020	Until 22/06/2030
PCR LÁTEX CEPA - Frasco 80047580198	C-reactive protein (CRP)	II	MBIOLOG DIAGNÓSTICOS LTDA	08/07/2019	Valid
ASLO LÁTEX CEPA_Frasco 80047580199	Antistreptolysin	II	MBIOLOG DIAGNÓSTICOS LTDA	08/07/2019	Valid
IMUNOCROM MB DENGUE NS1 80047580197	Dengue	III	MBIOLOG DIAGNÓSTICOS LTDA	08/04/2019	Until 08/04/2029
FATOR REUMATÓIDE LÁTEX CEPA 80047580195	Rheumatoid factor	II	MBIOLOG DIAGNÓSTICOS LTDA	05/11/2018	Valid
ASLO LÁTEX CEPA 80047580196	Antistreptolysin	II	MBIOLOG DIAGNÓSTICOS LTDA	05/11/2018	Valid
PCR LÁTEX CEPA 80047580194	C-reactive protein (CRP)	II	MBIOLOG DIAGNÓSTICOS LTDA	22/10/2018	Valid
IS HBSAG 80047580193	Hepatitis B surface antigen (HBsAg)	IV	MBIOLOG DIAGNÓSTICOS LTDA	27/11/2017	Until 27/11/2027
IMUNOCROM MB HCG 80047580192	Total human chorionic gonadotropin (hCG)	II	MBIOLOG DIAGNÓSTICOS LTDA	20/11/2017	Valid
ALLSERUM ZIKA IGM 80047580190	Zika virus IgM	IV	MBIOLOG DIAGNÓSTICOS LTDA	25/09/2017	Until 25/09/2027
ALLSERUM ZIKA IGG 80047580191	Zika virus IgG	IV	MBIOLOG DIAGNÓSTICOS LTDA	25/09/2017	Until 25/09/2027
IMUNOCROM MB DENGUE IGG/IGM 80047580189	Dengue	III	MBIOLOG DIAGNÓSTICOS LTDA	29/05/2017	Until 29/05/2027
IMUNOCROM MB HIV 1/2 80047580188	HIV-1/HIV-2 antibody	IV	MBIOLOG DIAGNÓSTICOS LTDA	08/05/2017	Until 08/05/2027
IMUNOCROM MB TROPONINA I 80047580187	Troponin	III	MBIOLOG DIAGNÓSTICOS LTDA	02/05/2017	Until 02/05/2027
IMUNOSCREEN HTLV I/II - SS 80047580185	Human T-lymphotropic virus 1 and 2 (HTLV-1/HTLV-2) antibody	IV	MBIOLOG DIAGNÓSTICOS LTDA	06/02/2017	Until 06/02/2027
IMUNOCROM MB HCV 80047580186	Total antibody to hepatitis C virus (anti-HCV)	IV	MBIOLOG DIAGNÓSTICOS LTDA	06/02/2017	Until 06/02/2027
PCR TURB CEPA 80047580172	C-reactive protein (CRP)	II	MBIOLOG DIAGNÓSTICOS LTDA	01/04/2013	Valid
Família de meios de cultura seletivos para determinados grupos de microorganismos MBiolog. 80047580169	Selective culture media for specific groups of microorganisms	I	MBIOLOG DIAGNÓSTICOS LTDA	28/05/2012	Valid
Fast Test HCG 80047580167	Self-test for human chorionic gonadotropin (hCG)	II	MBIOLOG DIAGNÓSTICOS LTDA	06/02/2012	Valid
Triglicérides Cepa 80047580166	Triglycerides	II	MBIOLOG DIAGNÓSTICOS LTDA	28/11/2011	Valid
IVB Colesterol - Papel Filtro 80047580164	Total cholesterol	II	MBIOLOG DIAGNÓSTICOS LTDA	10/10/2011	Valid
ASLO TURB CEPA 80047580161	Antistreptolysin	II	MBIOLOG DIAGNÓSTICOS LTDA	31/05/2011	Valid
Familia de meios de cultura para antibiograma 80047580157	Culture media and devices for antimicrobial susceptibility testing	II	MBIOLOG DIAGNÓSTICOS LTDA	21/03/2011	Valid
IVB-Glicose - Papel de Filtro 80047580154	Glucose	II	MBIOLOG DIAGNÓSTICOS LTDA	28/02/2011	Valid
FR TURB CEPA 80047580155	Rheumatoid factor	II	MBIOLOG DIAGNÓSTICOS LTDA	28/02/2011	Valid
IVB - Creatinina - Papel de Filtro 80047580152	Creatinine	II	MBIOLOG DIAGNÓSTICOS LTDA	07/02/2011	Valid

MBIOLOG DIAGNOSTICOS LTDA

Brazilian registration holders

Device types

Registrations (page 1 of 2, newest first)