Família CKMB

Creatine kinase isoenzymes (CK-MB, CK-BB, CK-MM) · class III · Until 03/08/2030

Registration no.
80027310288
Process no.
25351135910202013
Status
Until 03/08/2030
Device type
Creatine kinase isoenzymes (CK-MB, CK-BB, CK-MM) (CREATINOQUINASE ISOENZIMAS (CKMB, CKBB, CKMM))
Risk class
III
Registration holder
BIOTECNICA INDUSTRIA E COMERCIO LTDA CNPJ 02.534.069/0001-20 · 355 registrations
Manufacturer
BIOTECNICA INDUSTRIA E COMERCIO LTDA · Brazil
Published
03/08/2020
Valid until
03/08/2030
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