9.029.XXX.YY.ZZZ

Organization name

OPERON, S.A.

SRN

ES-MF-000004790

Manufacturer status

Active

Primary placement in Spain; available across 4 countries total.

Trade name

not provided

UDI-DI code

D-84295779029XZK9

Basic UDI-DI

B-84295779029XZK9

Reference / catalog number

9.029.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 for the detection of IgA-type antibodies against human tissue transglutaminase and against gliadins in human blood and serum. The results of this test are intended to aid in the diagnosis of coeliac disease (CD), taking into account the data available from the patient's clinical evaluation; the test does not constitute a definitive diagnosis itself. The test is qualitative. Test execution is not automated. Interpretation of the results can be done visually or by using the OPERON Lateral Flow Reader. This test is exclusively for in vitro diagnostic use. It is a professional use only product. It is not a device for near-patient testing. It is not a device self-testing.

Additional information URL

https://www.operondx.com/

Clinical sizes

No clinical sizes registered for this device.

• W01021699RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER

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