ABBOTT POINT OF CARE INC.: Brazil (ANVISA) registrations and registration holders

Product	Device type	Class	Holder	Published	Status
Família i-STAT hs-TnI 80146502426	Troponin	III	ABBOTT LABORATORIOS DO BRASIL LTDA	29/06/2026	Until 29/06/2036
Família i-STAT PT Plus 80146502422	Prothrombin time (PT)	III	ABBOTT LABORATORIOS DO BRASIL LTDA	11/05/2026	Until 11/05/2036
i-STAT CK-MB Cartridge 80146501949	Creatine kinase isoenzymes (CK-MB, CK-BB, CK-MM)	III	ABBOTT LABORATORIOS DO BRASIL LTDA	28/09/2015	Until 28/09/2035
Família i-STAT CK-MB Controls 80146501947	Creatine kinase isoenzymes (CK-MB, CK-BB, CK-MM)	III	ABBOTT LABORATORIOS DO BRASIL LTDA	08/09/2015	Until 08/09/2035
Família i-STAT TriControls 80146501936	Combined parameters in one product - class III	III	ABBOTT LABORATORIOS DO BRASIL LTDA	22/06/2015	Until 01/06/2036
Família de controles: i-STAT Total b-hCG Control 80146501910	Beta human chorionic gonadotropin (beta-hCG)	II	ABBOTT LABORATORIOS DO BRASIL LTDA	19/01/2015	Valid
i-STAT Total b-hCG Cartridge 80146501904	Beta human chorionic gonadotropin (beta-hCG)	II	ABBOTT LABORATORIOS DO BRASIL LTDA	15/12/2014	Valid
i-STAT Creatinine Cartridge 80146501905	Creatinine	II	ABBOTT LABORATORIOS DO BRASIL LTDA	15/12/2014	Valid
i-STAT CARTRIDGE TROPONIN I (cTnI) 80146501858	Troponin	III	ABBOTT LABORATORIOS DO BRASIL LTDA	07/10/2013	Until 07/10/2033
i-STAT CARTRIDGE EG7+ 80146501754	Combined parameters in one product - class III	III	ABBOTT LABORATORIOS DO BRASIL LTDA	25/04/2011	Until 27/07/2036
i-STAT PT Controls 80146501694	Prothrombin time (PT)	III	ABBOTT LABORATORIOS DO BRASIL LTDA	30/07/2010	Until 30/07/2035
i-STAT ACT Controls 80146501697	Activated clotting time (ACT)	III	ABBOTT LABORATORIOS DO BRASIL LTDA	30/07/2010	Until 30/07/2035
i-STAT BNP Controls 80146501689	Human brain natriuretic peptide (BNP)	III	ABBOTT LABORATORIOS DO BRASIL LTDA	26/07/2010	Until 21/09/2036
i-STAT Controls 80146501690	Combined parameters in one product - class II	II	ABBOTT LABORATORIOS DO BRASIL LTDA	26/07/2010	Valid
i-STAT Cardiac Markers Controls 80146501692	Combined parameters in one product - class III	III	ABBOTT LABORATORIOS DO BRASIL LTDA	26/07/2010	Until 26/07/2035
i-STAT CHEM 8+ CARTRIDGE 80146501578	Combined parameters in one product - class III	III	ABBOTT LABORATORIOS DO BRASIL LTDA	13/03/2009	Until 27/07/2036
i-STAT BNP CARTRIDGE 80146501545	Human brain natriuretic peptide (BNP)	III	ABBOTT LABORATORIOS DO BRASIL LTDA	25/08/2008	Until 06/07/2036
i-STAT PT/INR Cartridge 80146501510	Prothrombin time (PT)	III	ABBOTT LABORATORIOS DO BRASIL LTDA	22/04/2008	Until 22/04/2033
i-STAT KAOLIN ACT CARTRIDGE 80146501500	Activated clotting time (ACT)	III	ABBOTT LABORATORIOS DO BRASIL LTDA	18/02/2008	Until 18/02/2033
i-STAT CARTRIDGE CG8 + 80146501242	Combined parameters in one product - class III	III	ABBOTT LABORATORIOS DO BRASIL LTDA	23/05/2005	Until 22/06/2036
I-STAT CARTRIDGE CG4+ 80146501239	Combined parameters in one product - class III	III	ABBOTT LABORATORIOS DO BRASIL LTDA	13/05/2005	Until 28/09/2036
i-STAT CARTRIDGE EC8 + 10055310988	Combined parameters in one product - class II	II	ABBOTT LABORATORIOS DO BRASIL LTDA	26/05/2000	Valid
PORTABLE CLINICAL ANALYSER i-STAT E ACESSORIOS 10055310968	Cell and platelet analyzer or counter	II	ABBOTT LABORATORIOS DO BRASIL LTDA	10/01/2000	Valid

ABBOTT POINT OF CARE INC.

Brazilian registration holders

Device types

Registrations