HELENA LABORATORIES INC.: Brazil (ANVISA) registrations and registration holders

Product	Device type	Class	Holder	Published	Status
SPIFE® Nexus Alkaline Hemoglobin 10230730195	Hemoglobin	II	NL COMÉRCIO EXTERIOR LTDA	13/11/2023	Valid
Plateletworks® ADP Kit 10230730190	Platelet aggregation reagent/system	II	NL COMÉRCIO EXTERIOR LTDA	28/08/2023	Valid
SPIFE Nexus Blue 10230730188	Cytological stains	I	NL COMÉRCIO EXTERIOR LTDA	14/08/2023	Valid
SPIFE Nexus Violet 10230730189	Cytological stains	I	NL COMÉRCIO EXTERIOR LTDA	14/08/2023	Valid
SPIFE® Nexus Split Beta SPE-20, 40, 60, 80, 100 10230730185	Total protein	II	NL COMÉRCIO EXTERIOR LTDA	24/07/2023	Valid
SPIFE® Nexus lmmunoFix-6-9-15 10230730180	Combined parameters in one product - class II	II	NL COMÉRCIO EXTERIOR LTDA	26/06/2023	Valid
ImmunoFix Controls 10230730173	Combined parameters in one product - class II	II	NL COMÉRCIO EXTERIOR LTDA	16/11/2022	Valid
Família Controle SPE 10230730172	Combined parameters in one product - class II	II	NL COMÉRCIO EXTERIOR LTDA	13/10/2022	Valid
SPIFE NEXUS 10230730166	Protein electrophoresis instrument	II	NL COMÉRCIO EXTERIOR LTDA	18/08/2022	Valid
Família Hemo Control 10230730163	Hemoglobin	II	NL COMÉRCIO EXTERIOR LTDA	07/07/2022	Valid
LipoTrol 10230730165	Lipoprotein	II	NL COMÉRCIO EXTERIOR LTDA	07/07/2022	Valid
Actalyke Analyzers 10230730153	Hemostasis analyzer	II	NL COMÉRCIO EXTERIOR LTDA	20/01/2022	Valid
Cascade Abrazo PT-WB 10230730151	Prothrombin time (PT)	III	NL COMÉRCIO EXTERIOR LTDA	27/12/2021	Until 27/12/2031
Família Cascade Abrazo c-ACT 10230730136	Activated clotting time (ACT)	III	NL COMÉRCIO EXTERIOR LTDA	23/11/2020	Until 23/11/2030
ESH - Electrophoresis Sample Handler 10230730110	Sample preparation equipment for in vitro diagnostics	I	NL COMÉRCIO EXTERIOR LTDA	20/10/2015	Valid
CASCADE ABRAZO 10230730109	Hemostasis analyzer	II	NL COMÉRCIO EXTERIOR LTDA	31/08/2015	Valid
Cascade POC TCA-c 10230730106	Activated clotting time (ACT)	III	NL COMÉRCIO EXTERIOR LTDA	13/07/2015	Until 13/07/2035
CUBA DE ELETROFORESE QUICKGEL 10230739002	Protein electrophoresis instrument	II	NL COMÉRCIO EXTERIOR LTDA	10/06/2014	Valid
AGREGÔMETRO PLAQUETÁRIO AGGRAM 10230730104	Hemostasis analyzer	II	NL COMÉRCIO EXTERIOR LTDA	27/05/2013	Valid
Família Controle Cascade POC TCA-c 10230730092	Activated clotting time (ACT)	III	NL COMÉRCIO EXTERIOR LTDA	21/12/2009	Until 21/12/2034
Família Kit para Eletroforese de Hemoglobina Ácida 10230730081	Hemoglobin variants	II	NL COMÉRCIO EXTERIOR LTDA	14/10/2009	Valid
QUICKGEL Split Beta SPE 10230730084	Total protein	II	NL COMÉRCIO EXTERIOR LTDA	14/10/2009	Valid
Solução REP PREP 10230730085	Buffers, diluents and other solutions for laboratory analysis	I	NL COMÉRCIO EXTERIOR LTDA	14/10/2009	Valid
Epinefrina 10230730076	Catecholamines (noradrenaline, adrenaline, dopamine and derivatives)	II	NL COMÉRCIO EXTERIOR LTDA	05/10/2009	Valid
ANALISADOR SPIFE 10230730072	Protein electrophoresis instrument	II	NL COMÉRCIO EXTERIOR LTDA	12/03/2007	Valid

HELENA LABORATORIES INC.

Brazilian registration holders

Device types

Registrations