Data from EUDAMED, last updated Jun 11, 2026

COVID-19 & Influenza A/B Rapid Test Cassette (Swab)

B-GCFC-525SaM8

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

ReagentProfessional testingAnimal tissues / cells

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
COVID-19 & Influenza A/B Rapid Test Cassette (Swab)	`GCFC-525Sa`	`D-GCFC-525SaM8`	1	On the market