Logilet Respiratory Pathogen Panel

Trade name

Logilet Respiratory Pathogen Panel

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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06973315734882

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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6973315734882AY

Reference / catalog number

VD1011

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

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.

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IVDR Class B

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

In the current context ofthe ongoing COVlD-19 pandemic and seasonal influenza outbreaks, the ability to simultaneously detect nucleic acid ofamong RSV, Flu A, Flu B, SARS-COV-2, HAdV and MP in a single test is crucial for efficient and accurate diagnosis. This kit leverages RT-PCR-based technology, known for its high sensitivity and specificity, to provide rapid and reliable results, thereby enhancing the state of the art in respiratory virus detection and contributing to improved patient care and public health measures. This product adopts digital microfluidic technology. Applicable to the Logilet Logicore system The test kit contains all the reaction components required for nucleic acid extraction and purification of clinical samples, reverse transcription PCR and PCR detection processes. These components are respectively encapsulated in each blister and freeze-dried bulb of the test kit. forming a closed system. Digital microfluidic technology utilizes electric potential to regulate the surface energy of liquids and solids, thereby achieving precise quantitative control of independent tiny droplets. The quantitative accuracy is less than 1 microliter. The liquid driving force is entirely derived firom the conductive electrodes located within the chip, no longer relying on peripheral devices such as mechanical pumps, thus reducing the complexity of the system.

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.

• W0105070503RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS