9.230.XXX.YY.ZZZ

Organization name

OPERON, S.A.

SRN

ES-MF-000004790

Manufacturer status

Active

Primary placement in Spain; available across 6 countries total.

Trade name

not provided

UDI-DI code

D-84295779230XUJF

Basic UDI-DI

B-84295779230XUJF

Reference / catalog number

9.230.XXX.YY.ZZZ

Issuing entity

EUDAMED

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

One-step immunochromatographic test to aid in the diagnosis of the gastrointestinal infection caused by Campylobacter by qualitative detection of its antigens in human faeces. The results of this test are intended to support data derived from a clinical evaluation of the patient; the test does not constitute a definitive diagnosis in itself. The test is qualitative and its execution is not automated, although results interpretation can be done using a strip reader. This test is exclusively for in vitro diagnostic use. It is a professional use test. It is not a near patient device. It is not a self test product.

Additional information URL

https://www.operondx.com/

Clinical sizes

No clinical sizes registered for this device.

• W0105090199BACTERIOLOGY - RT & POC - OTHER

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