EUDAMED last updated this device on May 11, 2026

Flu A/RSV Ag Combo Rapid Test Cassette (Swab)

B-GCFR(A)-T502aMC

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Zhejiang Orient Gene Biotech Co., Ltd
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: D-GCFR(A)-T502aMC
Reference / catalog number: GCFR(A)-T502a

Flu A/RSV Ag Combo Rapid Test Cassette (Swab) is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Zhejiang Orient Gene Biotech Co., Ltd. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Role
Country
Date of registration
Address

EUDAMED last updated this device on May 11, 2026

Flu A/RSV Ag Combo Rapid Test Cassette (Swab)

B-GCFR(A)-T502aMC

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Zhejiang Orient Gene Biotech Co., Ltd
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: D-GCFR(A)-T502aMC
Reference / catalog number: GCFR(A)-T502a

View device family (Basic UDI)

Device identification

Trade name: Flu A/RSV Ag Combo Rapid Test Cassette (Swab)
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: D-GCFR(A)-T502aMC
Basic UDI-DI The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key. View in glossary →: B-GCFR(A)-T502aMC
Reference / catalog number: GCFR(A)-T502a
UDI issuing entities Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system. View in glossary →: EUDAMED

Classification

IVDR risk classes IVDR risk classes rank in-vitro diagnostic devices from lowest risk (Class A) to highest (Class D), based on the patient and public-health risk of a wrong result. View in glossary →: IVDD — General
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: The Flu A/RSV Ag Combo Rapid Test Cassette (Swab) is an in vitro immunochromatographic assay for the qualitative and differential detection of Respiratory Syncytial Virus (RSV) and influenza A antigens in nasal swab specimens directly from individuals within the first ten days of symptom onset. It is intended to aid in the rapid diagnosis of Respiratory Syncytial Virus (RSV) and influenza A infections. This test provides only a preliminary test result. Therefore, any reactive specimen with the Flu A/RSV Ag Combo Rapid Test Cassette (Swab) must be confirmed with alternative testing method(s) and clinical findings.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

D-GCFR(A)-T502aMC

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

W0105099099VIROLOGY - RT & POC - OTHER

Critical warnings

3 warnings recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Certificates covering this device

No certificate specifically references this device's Basic UDI-DI.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement		Still on market

Device identification

Trade name: Flu A/RSV Ag Combo Rapid Test Cassette (Swab)
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: D-GCFR(A)-T502aMC
Basic UDI-DI The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key. View in glossary →: B-GCFR(A)-T502aMC
Reference / catalog number: GCFR(A)-T502a
UDI issuing entities Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system. View in glossary →: EUDAMED

Classification

IVDR risk classes IVDR risk classes rank in-vitro diagnostic devices from lowest risk (Class A) to highest (Class D), based on the patient and public-health risk of a wrong result. View in glossary →: IVDD — General
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: The Flu A/RSV Ag Combo Rapid Test Cassette (Swab) is an in vitro immunochromatographic assay for the qualitative and differential detection of Respiratory Syncytial Virus (RSV) and influenza A antigens in nasal swab specimens directly from individuals within the first ten days of symptom onset. It is intended to aid in the rapid diagnosis of Respiratory Syncytial Virus (RSV) and influenza A infections. This test provides only a preliminary test result. Therefore, any reactive specimen with the Flu A/RSV Ag Combo Rapid Test Cassette (Swab) must be confirmed with alternative testing method(s) and clinical findings.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

Manufacturer information

Organization name: Zhejiang Orient Gene Biotech Co., Ltd
SRN: CN-MF-000017965
Manufacturer status: Active

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

D-GCFR(A)-T502aMC

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

By subscribing you accept the Privacy Policy.

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

W0105099099VIROLOGY - RT & POC - OTHER

Critical warnings

3 warnings recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Certificates

Certificate health across this manufacturer's portfolio.

V10 092305 0004Supplemented
Quality management system
Notified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →
: 0123Expiry: Feb 27, 2029
CR-04-1249-874-25Supplemented
Quality management system
Notified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →
: 0537Expiry: Apr 17, 2030
CR-04-1249-875-25Issued
Technical documentation
Notified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →
: 0537Expiry: Apr 17, 2030

Certificates covering this device

No certificate specifically references this device's Basic UDI-DI.

All products by Zhejiang Orient Gene Biotech Co., Ltd

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement		Still on market

Flu A/RSV Ag Combo Rapid Test Cassette (Swab)

Flu A/RSV Ag Combo Rapid Test Cassette (Swab)

Device identification

Classification

Device details

UDI-PI traceability

UDI-DI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Certificates covering this device

Market distribution

Related searches

Device identification

Classification

Device details

Manufacturer information

UDI-PI traceability

UDI-DI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Certificates

Certificates covering this device

Related devices

Market distribution

Related searches

Manufacturer information

Certificates

Related devices