9.038.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-84295779038Y2GY

Basic UDI-DI

B-84295779038Y2GY

Reference / catalog number

9.038.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

OPERON's 2A-Bdiff chromatographic immunoassay provides a procedure for a qualitative detection of Clostridium difficile toxin A (TcdA) and toxin B (TcdB) in two separate bands. A positive band of either toxin is a sign of an underlying Clostridium difficile infection (CDI), which should be taken into consideration by the clinician. Unlike other immunoassay systems (ELISA and rapid tests) that only allow detection of TcdA and TcdB in combination and without any differentiation between the two, the OPERON 2A-Bdiff test allows you to run a single assay with a single strip that differentiates between both of the toxins using two separated bands - a red band below the blue control band when TcdA is present, and another red band above the control band when TcdB is in the sample (see Fig. 1). The test is based on the immunological capture of coloured microparticles during their passage along a membrane on which specific monoclonal antibodies against TcdA and TcdB have been immobilised at two separated locations.

Additional information URL

https://www.operondx.com/

Clinical sizes

No clinical sizes registered for this device.

• W0105090106CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT & POC

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