ID CORE CONTROL

Registration no.: 80134860315
Process no.: 25351389138202473
Status: Until 30/06/2035
Device type: Immunohematology - Rh-hr, Kell, Kidd, Duffy - monoclonal source (IMUNOHEMATOLOGIA - RH-HR, KELL, KIDD, DUFFY - ORIGEM MONOCLONAL)
Risk class: IV
Registration holder: GRIFOLS BRASIL LTDA CNPJ 02.513.899/0001-71 · 342 registrations
Manufacturer: PROGENIKA BIOPHARMA S.L. · Spain
Published: 30/06/2025
Valid until: 30/06/2035
Last updated by ANVISA: 2026-10-12
Official record: View on ANVISA ↗

Other immunohematology - rh-hr, kell, kidd, duffy - monoclonal source registrations (33 in total, see all)

Product	Class	Holder	Published	Status
Família Fenotipagem Estendida Monoclonal (Sistemas Kell, Duffy, Perfil II, III) 80020690487	IV	BIO-RAD LABORATORIOS BRASIL LTDA	22/06/2026	Until 22/06/2036
FAMÍLIA: REAGENTES PARA IMUNOHEMATOLOGIA - Rh-Hr - KELL, KIDD, DUFFY- NACIONAL 80020690465	IV	BIO-RAD LABORATORIOS BRASIL LTDA	14/07/2025	Until 19/01/2035
Família RH-HR, KELL, KIDD, DUFFY Monoclonal Importado – Gel Teste 80020690472	IV	BIO-RAD LABORATORIOS BRASIL LTDA	14/07/2025	Until 10/07/2027
FAMÍLIA RH-HR, KELL, KIDD, DUFFY MONOCLONAL IMPORTADO- CONVENCIONAL 80020690474	IV	BIO-RAD LABORATORIOS BRASIL LTDA	14/07/2025	Until 25/11/2034
ID RHD XT REAGENTES 80134860307	IV	GRIFOLS BRASIL LTDA	18/03/2024	Until 18/03/2034
Família RH-HR Monoclonal 80022230264	IV	GOLD ANALISA DIAGNOSTICA LTDA	13/02/2023	Until 13/02/2033
Família Anti-Kpa Dual e Anti-Kpb Dual 80134860261	IV	GRIFOLS BRASIL LTDA	03/06/2019	Until 03/06/2029
Família Gamma-clone Anti-Jka e Anti-Jkb 10154450197	IV	FRESENIUS HEMOCARE BRASIL LTDA.	28/01/2019	Until 28/01/2029