BODITECH MED INCORPORATED: Brazil (ANVISA) registrations and registration holders

Product	Device type	Class	Holder	Published	Status
Boditech TSH Plus Control 10350840424	Thyroid-stimulating hormone (TSH)	II	BIOSYS LTDA	14/07/2022	Valid
AFIAS COVID-19/Flu Ag Combo 10350840415	Combined parameters - respiratory panel	III	BIOSYS LTDA	07/02/2022	Until 07/02/2032
ichroma COVID-19/Flu Ag Combo 10350840416	Combined parameters - respiratory panel	III	BIOSYS LTDA	07/02/2022	Until 07/02/2032
Família ichroma AMH 10350840410	Anti-Müllerian hormone (AMH)	II	BIOSYS LTDA	19/08/2021	Valid
ichroma IL-6 10350840398	Interleukins	II	BIOSYS LTDA	11/03/2021	Valid
Familia Boditech CK-MB 10350840391	Creatine kinase isoenzymes (CK-MB, CK-BB, CK-MM)	III	BIOSYS LTDA	11/01/2021	Until 11/01/2031
ichroma Influenza A + B 10350840385	Influenza A and B viruses	III	BIOSYS LTDA	19/10/2020	Until 19/10/2030
Boditech hCG Calibrator 10350840382	Beta human chorionic gonadotropin (beta-hCG)	II	BIOSYS LTDA	01/10/2020	Valid
AFIAS Anti-CCP Plus 10350840379	Anti-cyclic citrullinated peptide (anti-CCP)	II	BIOSYS LTDA	24/09/2020	Valid
ichroma Zika IgG/IgM 10350840372	Zika virus IgM/IgG	IV	BIOSYS LTDA	03/08/2020	Until 03/08/2030
Família AFIAS COVID-19 Ag 10350840368	Coronavirus	III	BIOSYS LTDA	13/07/2020	Until 13/07/2030
ichroma COVID-19 Ag 10350840369	Coronavirus	III	BIOSYS LTDA	13/07/2020	Until 13/07/2030
ichroma COVID-19 Ab 10350840365	Coronavirus	III	BIOSYS LTDA	27/04/2020	Until 27/04/2030
AFIAS Total B-HCG 10350840341	Beta human chorionic gonadotropin (beta-hCG)	II	BIOSYS LTDA	29/10/2018	Valid
Família Boditech Cardiac 10350840338	Combined parameters in one product - class III	III	BIOSYS LTDA	15/10/2018	Until 15/10/2028
ichroma TSH Plus 10350840323	Thyroid-stimulating hormone (TSH)	II	BIOSYS LTDA	23/07/2018	Valid
Família Vitamin D 10350840310	Vitamin D	II	BIOSYS LTDA	19/03/2018	Valid
Boditech Hormone Control 10350840307	Combined parameters in one product - class II	II	BIOSYS LTDA	08/01/2018	Valid
Hemochroma Plus 10350840303	Cell and platelet analyzer or counter	II	BIOSYS LTDA	16/10/2017	Valid
i-chamber 10350840301	Sample preparation and processing instrument - pre-analytical phase	I	BIOSYS LTDA	31/07/2017	Valid
ichroma™ Reader 10350849001	Immunoassay instrument	II	BIOSYS LTDA	30/11/2015	Valid

BODITECH MED INCORPORATED

Brazilian registration holders

Device types

Registrations