Data from EUDAMED, last updated Jun 11, 2026

COVID-19/Flu A&B/RSV/Adeno/HPIV/HMPV/RhV/M. pneumoniae Ag Combo Rapid Test Cassette (Swab)

B-GCRESA-T555aNB

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

Device name: COVID-19/Flu A&B/RSV/Adeno/HPIV/HMPV/RhV/M. pneumoniae Ag Combo Rapid Test Cassette (Swab)
Basic UDI-DI: B-GCRESA-T555aNB
Device model: GCRESA-T555a
Issuing agency: EUDAMED
Version date: May 12, 2026

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/Flu A&B/RSV/Adeno/HPIV/HMPV/RhV/M. pneumoniae Ag Combo Rapid Test Cassette (Swab)	`GCRESA-T555a`	`D-GCRESA-T555aNB`	1	On the market