Data from EUDAMED, last updated Jun 12, 2026

Alpha Fetoprotein (AFP) Assay Kit (Chemiluminescent Immunoassay)

B-06970522641057

1 reference

IVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Risk category: IVDD — General
Manufacturer: Sichuan Orienter Biotechnology Co., Ltd.

Device family identification

Device name: Alpha Fetoprotein (AFP) Assay Kit (Chemiluminescent Immunoassay)
Basic UDI-DI: B-06970522641057
Device model: 2×50 test/box Calibrator:0.5mL×2
Issuing agency: EUDAMED
Version date: May 18, 2026

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

ReagentProfessional 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
Alpha Fetoprotein (AFP) Assay Kit (Chemiluminescent Immunoassay)	`DD0101`	`06970522641057`	1	On the market