LYHER

Trade name

LYHER

UDI-DI code

06972412613823

Basic UDI-DI

0697241261IRS-572BQ

Reference / catalog number

303041901

Issuing entity

GS1

Risk category

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

"The Respiratory multiple 7 in 1 test kit (FluA/FluB/COVID-19/RSV/Adeno/MP/HMPV) is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2, influenza A virus, influenza B virus, respiratory syncytial virus (RSV) Adenovirus Mycoplasma pneumoniae or human metapneumovirus in nasopharyngeal swab, oropharyngeal swab or nasal swab specimens. The device detects any combination of the above viruses. Antigen tests are generally used for acute phase of infection, this test detects the antigen in specimen from individuals who are suspected of relative virus infection within 7 days of symptom onset. This test only provides an aid to diagnosis of novel coronavirus (SARS-CoV-2), influenza A virus, influenza B virus, RSV, Adenovirus Mycoplasma pneumoniae infection and human metapneumovirus infection. The infection status should be determined in combination with other diagnostic information such as PCR tests or medical image science, exposures and medical history. Positive results only indicate the presence of viral antigens in specimens and cannot determine the infection status. Positive results can be used for patient diversion and rapid management decisions. Negative results cannot rule out the SARS-CoV-2, influenza A virus, influenza B virus, RSV, Adenovirus Mycoplasma pneumoniae infection or human metapneumovirus infection, and should not be used as sole basis for treatment or patient management decisions. Both positive and negative results for suspected cases should be determined by a further molecular assay (e.g., PCR 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.

• W0105090699OTHER MULTIPLE PATHOGENS - RT & POC

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