Luminis FIA CK-MB

Creatine kinase isoenzymes (CK-MB, CK-BB, CK-MM) · class III · Until 08/09/2035

Registration no.
80474870168
Process no.
25351098583202516
Status
Until 08/09/2035
Device type
Creatine kinase isoenzymes (CK-MB, CK-BB, CK-MM) (CREATINOQUINASE ISOENZIMAS (CKMB, CKBB, CKMM))
Risk class
III
Registration holder
BIOSUL PRODUTOS DIAGNOSTICOS LTDA - ME CNPJ 05.905.525/0001-90 · 186 registrations
Manufacturer
QINGDAO HIGHTOP BIOTECH CO.,LTD. · China
Published
08/09/2025
Valid until
08/09/2035
Last updated by ANVISA
2026-10-12
Official record
View on ANVISA ↗

Other creatine kinase isoenzymes (ck-mb, ck-bb, ck-mm) registrations (101 in total, see all)

ProductClass HolderPublishedStatus
Creatina Quinase MB STAT (CK-MB STAT) eCLIA
80102513735
III VR MEDICAL IMPORTADORA E DISTRIBUIDORA DE PRODUTOS MÉDICOS LTDA 21/09/2026 Until 21/09/2036
Família CK-MB
80943610335
III MINDRAY DO BRASIL COMÉRCIO E DISTRIBUIÇÃO DE EQUIPAMENTOS MÉDICOS LTDA. 22/06/2026 Until 22/06/2036
Família CK-MB UV
10303460615
III IN VITRO DIAGNOSTICA LTDA 15/06/2026 Until 15/06/2036
Família CK-MB cobas e
10287411792
III ROCHE DIAGNÓSTICA BRASIL LTDA 18/05/2026 Until 18/05/2036
SMART CK-MB
80074330056
III GLOBO REAGENTES E EQUIPAMENTOS P/ LABORATORIOS LTDA 05/01/2026 Until 05/01/2036
Família CK-MB Quantitative Test Kit (Time-Resolved FIA)
82444370309
III Enzytec Biotecnologia Ltda. 29/12/2025 Until 29/12/2035
Família CK-MB
80254180485
III PHADIA DIAGNOSTICOS LTDA 22/12/2025 Until 22/12/2035
CK-MB FIA Assure Test
80885650101
III ORBITAE DIAGNOSTICOS S/A 03/11/2025 Until 03/11/2035