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illumigene C. difficile External Control Kit

FDA UDI

Class I (US FDA UDI)

by Meridian Bioscience, Inc.

Identity

Trade Name
illumigene C. difficile External Control Kit FDA UDI
Generic Name
Clostridium difficile nucleic acid IVD, control FDA UDI
Device Name
The illumigene C. difficile External Control Kit contains Positive and Negative Control Reagents for use with the illumigene C. difficile test kit. External controls are used as part of a routine quality control program. FDA UDI
Model / Reference
279920 FDA UDI
Description
The illumigene C. difficile External Control Kit contains Positive and Negative Control Reagents for use with the illumigene C. difficile test kit. External controls are used as part of a routine quality control program. FDA UDI

Identifiers

Catalog Number
279920 FDA UDI
Primary DI / UDI-DI
00840733101120 FDA UDI
FDA Product Code
OMN FDA UDI
GMDN Term
Clostridium difficile nucleic acid IVD, control FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.2660 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

illumigene C. difficile External Control Kit by Meridian Bioscience, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Meridian Bioscience, Inc.

Sources (1)

  • FDA UDI 1b428fbf-3f8b-458c-8826-3152244f8c7a 37 fields · synced May 31, 2026