STANDARD™ M10 C. difficile BT

Trade name

STANDARD™ M10 C. difficile BT

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

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08800111723117

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

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88001117IPBA01MA05WV

Reference / catalog number

11CDC20A

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

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GS1

Risk category

IVDR risk classes

IVDR risk classes rank in-vitro diagnostic devices from lowest risk (Class A) to highest (Class D), based on the patient and public-health risk of a wrong result.

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IVDR Class B

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

10

Additional product description

STANDARD M10 C. difficile BT is a multiplex real-time PCR test intended for use with the STANDARD M10 system to qualitatively detect the bacterial DNA of toxigenic Clostridioides difficile, including tcdB, cdtA, and the tcdC deletion at nucleotide(nt) 117, from unformed (liquid or soft) stool specimens collected from patients suspected of having Clostridium difficile infection (CDI). The STANDARD M10 C. difficile BT is intended as an aid in the diagnosis of CDI and detection of strains potentially associated with more severe disease. Positive results indicate the presence of toxigenic C. difficile, while a positive result for tcdB, binary toxin and the tcdC deletion at nt 117 suggests presumptive PCR ribotype 027 C. difficile. Clinical correlation with patient history and other diagnostic information is necessary to determine the patient's infection status. Negative results should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information. This test is intended to be performed by trained users in a laboratory setting and is not intended for use in near-patient testing environments.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• W0105011804C.DIFFICILE BY NA REAGENTS

15 warnings recorded — scroll inside the panel to see all entries.

• CW007

  EUDAMED did not publish a description for this code.
• CW009

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• CW084

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• CW158

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• CW162

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• CW167

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• CW193

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• CW194

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• CW444

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• CW430

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• CW401

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• CW416

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• CW397

  EUDAMED did not publish a description for this code.
• CW999

  P310: Immediately call a POISON CENTER or doctor/physician. P321: Specific treatment. P363: Wash contaminated clothing before reuse. P501: Dispose of contents/container in accordance with local/regional/national/international regulation.
• CW081

  EUDAMED did not publish a description for this code.

No certificate specifically references this device's Basic UDI-DI.