9.024.020.16.000

Organization name

OPERON, S.A.

SRN

ES-MF-000004790

Manufacturer status

Active

Primary placement in Spain; available across 7 countries total.

Trade name

not provided

UDI-DI code

08429577008257

Basic UDI-DI

84295779024XP

Reference / catalog number

9.024.020.16.000

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

20

Additional product description

A single-step immunochromatographic test to aid in the diagnosis of the gastrointestinal infection caused by Rotavirus and Adenovirus by means of the qualitative detection, on separated bands, of Rotavirus and Adenovirus antigens in human stools. Simple/Stick Rota-Adeno test results should be evaluated by doctors in combination with other clinical information about the patient. They should not be used as the only criterion for diagnosing the infection. The test is qualitative and its execution is not automated, although the results can be interpreted visually or using a lateral flow reader This test is exclusively for in vitro diagnostic use. This test is for professional use. This is not a diagnostic test for use at the patient care location. This is not a self-diagnostic test.

Additional information URL

https://ifus.operon.es/

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.

• W0105099099VIROLOGY - RT & POC - OTHER