AQ+Rapid SARS-CoV-19/ Flu Combo Test

Trade name

AQ+Rapid SARS-CoV-19/ Flu Combo Test

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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06936155808403

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-06936155808403

Reference / catalog number

ITP16050-TC1

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

The AQ+ Rapid COVID-19/Flu Combo Test is a colloidal gold enhanced, rapid immunochromatographic assay for qualitative detection of antigens to SARS-CoV-2 and Influenza A and Influenza B present in human nasopharyngeal/nasal specimens. The test is used as an aid in the diagnosis of COVID-19 infection and/or Influenza A and Influenza B. COVID-19 and Influenza are both contagious respiratory illnesses caused by different viruses, and because symptoms of COVID-19, influenza and other respiratory illnesses may be similar, testing is needed to help differentiate the illness and confirm diagnosis. The device can distinguish SARS-CoV-2 viral antigens from Influenza A or Influenza B viral antigens from a single specimen using a single device, providing simple visual qualitative results within 20 minutes. The assay principle is based on gold-conjugated mouse anti-SARS-CoV-2 N-protein IgG, gold-conjugated mouse anti-influenza A nucleoprotein IgG and gold-conjugated mouse anti-influenza B nucleoprotein IgG reacting with the corresponding target antigens in the specimen to form immune complexes, which migrate along the test strip and are captured in the respective test band regions to produce visible colored bands when the target antigen concentration is above the detection limit. A control band formed by goat anti-mouse IgG must appear for the result to be valid.

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.

• W0105090601CORONAVIRUS / INFLUENZA - RT & POC

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

• CW011

  For in vitro diagnostic use only. Please read and strictly follow the instructions for use. Strict personal protection is required throughout the test. This product is for diagnosis of SARS-CoV-2, Influenza A and Influenza B infection only, and clinical diagnosis should not be made based only on the product result. Negative results cannot rule out the possibility of exposure to or infection of Influenza A, Influenza B or SARS-CoV-2. Positive specimens should be confirmed using an appropriate test such as RT-PCR or equivalent. Do not use pooled specimens or specimens other than specified, such as urine or blood. Do not perform the test under conditions leading to rapid evaporation, such as >40°C and <40% RH, or close to a running fan or air conditioner.
• CW010

  Read the instructions for use carefully before use and follow the procedure strictly.
• CW008

  Treat all specimens and potentially contaminated materials as infectious. Follow good microbiological practices, wear disposable gloves, avoid contact of gloved hands with the face, and decontaminate and dispose of specimens, reagents and other potentially contaminated materials as infectious waste in a biohazard container.
• CW009

  Do not reuse the cassette, swab or buffer tube.
• CW007

  Do not use the swab if the package is damaged or the seal is broken. Do not use the test cassette if the foil pouch is damaged or the seal is broken.
• CW032

  Do not use expired reagents or test cassettes.

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