Data from EUDAMED, last updated Jun 11, 2026

CK-MB Quantitative Test Kit (Time-Resolved FIA)

B-FDCKM-402aVZ

1 reference

IVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Risk category: IVDD — General
Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd

Device family identification

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Risk category: IVDD — General
Status: On the market

ReagentNear-patient testingProfessional testing

European Medical Device Nomenclature — the EU product classifications carried across this device family's references.

References

1 reference

Trade name	Reference / catalog number	UDI-DI code	Quantity	Status
CK-MB Quantitative Test Kit (Time-Resolved FIA)	`FDCKM-402a`	`D-FDCKM-402aVZ`	1	On the market