COVID-19 (SARS-CoV-2)Antigen Test Kit(Colloidal Gold)Saliva

Trade name

COVID-19 (SARS-CoV-2)Antigen Test Kit(Colloidal Gold)Saliva

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.

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06952062777816

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.

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B-06952062777816

Reference / catalog number

SL030101SST-1

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.

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GS1

Risk category

IVDD — General

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

This product is used for in vitro qualitative detection of the SARS-CoV-2 antigen inhuman saliva specimen. This product is intended for home self-testing as a rapid test fornovel coronavirus infection. Both symptomatic and asymptomatic infections can betested. However, please do not make a medical relevance decision without consultingwith your doctor. This product is suitable for users aged 10 and over. Parents or eligible adults shouldassist users under the age of 10 to complete the test.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

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

• W0105099099VIROLOGY - RT & POC - OTHER

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.

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