CK-MB FIA Assure Test
Creatine kinase isoenzymes (CK-MB, CK-BB, CK-MM) · class III · Until 03/11/2035
- Registration no.
- 80885650101
- Process no.
- 25351147225202536
- Status
- Until 03/11/2035
- Device type
- Creatine kinase isoenzymes (CK-MB, CK-BB, CK-MM) (CREATINOQUINASE ISOENZIMAS (CKMB, CKBB, CKMM))
- Risk class
- III
- Registration holder
- ORBITAE DIAGNOSTICOS S/A CNPJ 11.162.384/0001-65 · 111 registrations
- Manufacturer
- Published
- 03/11/2025
- Valid until
- 03/11/2035
- 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)
| Product | Class | Holder | Published | Status |
|---|---|---|---|---|
| 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 |
| FAMÍLIA CK MB
10377390332 |
III | KATAL BIOTECNOLOGICA INDUSTRIA E COMERCIO LTDA | 13/10/2025 | Until 13/10/2035 |