Data from EUDAMED, last updated Jun 11, 2026

COVID-19/Flu A&B/RSV/Adeno Ag Control Kit

B-GCFCRA-PN27N

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 testing

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

Data from EUDAMED, last updated Jun 11, 2026

B-GCFCRA-PN27N

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

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.

1 reference

Trade name	Reference / catalog number	UDI-DI code	Quantity	Status
COVID-19/Flu A&B/RSV/Adeno Ag Control Kit	`GCFCRA-PN2`	`D-GCFCRA-PN27N`	1	On the market