EntericBio® C.difficile plug-in

Organization name

Serosep Limited

SRN

IE-MF-000020322

Manufacturer status

Active

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• CW010

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Primary placement in Ireland; available across 1 country total.

Trade name

EntericBio® C.difficile plug-in

UDI-DI code

05391513879562

Basic UDI-DI

0539151387CDIFFPY4

Reference / catalog number

EBFFS - CDA

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

For in vitro diagnostic use. The EntericBio® C. difficile plug-in, which runs on the UgenTec FastFinder platform, is an optional software that can be used in conjunction with the EntericBio® Clostridioides difficile molecular diagnostic test, to aid in the diagnosis of Clostridioides difficile infection. The EntericBio® C. difficile plug-in is a qualitative molecular diagnostic software that provides automated analysis and interpretation of the EntericBio® Clostridioides difficile test data generated by the Roche LightCycler® 480 II PCR instrument. The EntericBio® C. difficile plug-in reports on the detection of nucleic acids from Clostridioides difficile in human stool samples from patients symptomatic of Clostridioides difficile infection. The plug-in is intended for use by suitably trained laboratory personnel in a clinical laboratory setting.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W02050192NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE

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