illumigene C. difficile External Control Kit

Basic Information

• Brand Name: illumigene C. difficile External Control Kit
• Primary DI: 00840733101120
• Version / Model: 279920
• Catalog Number: 279920
• Company Name: MERIDIAN BIOSCIENCE, INC.
• Labeler DUNS: 092815364
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 3
• Public Version Date: 2020-07-16
• Public Version Status: Update
• Public Device Record Key: 1b428fbf-3f8b-458c-8826-3152244f8c7a
• Distribution End Date: 2020-02-20

Device 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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OMN	C. Difficile Nucleic Acid Amplification Test Assay	Microbiology	866.2660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
50838	Clostridium difficile nucleic acid IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid, including specific gene markers, from Clostridium difficile bacteria [e.g., genes conferring antimicrobial resistance (e.g., gyrA gene), virulence (e.g., ribotype 027), and genes encoding toxin A and/or B] in a clinical specimen and/or culture isolate.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840733101120	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius