SARS-CoV-2 Delta-series Mutant Strain Ag Rapid Test Cassette (Swab)

Organization name

Healgen Scientific Limited Liability Company

SRN

US-MF-000018839

Manufacturer status

Active

D-GCCOV(Del)-T502aHGQG

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

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

• Consult instructions for use
• Do not re-use
• Do not use if package is damaged

Primary placement in Germany; available across 1 country total.

Placed on the market in Germany; per-country availability dates not published.

Trade name

SARS-CoV-2 Delta-series Mutant Strain Ag Rapid Test Cassette (Swab)

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

D-GCCOV(Del)-T502aHGQG

Basic UDI-DI

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.

B-GCCOV(Del)-T502aHGQG

Reference / catalog number

GCCOV(Del)-T502a

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

EUDAMED

Risk category

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.

IVDD — General

Applicable legislation

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

The SARS-CoV-2 Delta-series Mutant Strain Ag Rapid Test Cassette (Swab) is an in vitro immunochromatographic assay for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct nasal swab specimens directly from individuals who are both symptomatic and asymptomatic and to differentiate between the wild-type SARS-CoV-2 and Delta-series mutant strains. It can be used to rapidly detect whether patients are infected with SARS-CoV-2 and distinguish between wild-type SARS-CoV-2 and Delta-series mutant strains infection. Negative results from patients with symptom onset beyond ten days, should be treated as presumptive and confirmation with a molecular assay, if necessary, for patient management, may be performed. The SARS-CoV-2 Delta-series Mutant Strain Ag Rapid Test Cassette (Swab) does not differentiate between SARS-CoV and SARS-CoV-2.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

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

• W0105090501CORONAVIRUS ANTIGEN (AG) - RT & POC

• IVDD — General medical devices in EUDAMED

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