CHORUS CLIA CLOSTRIDIUM DIFFICILE GDH

Basic Information

• Brand Name: CHORUS CLIA CLOSTRIDIUM DIFFICILE GDH
• Primary DI: 08033891322748
• Version / Model: 82306
• Catalog Number: 82306
• Company Name: DIESSE DIAGNOSTICA SENESE SPA
• Labeler DUNS: 435036669
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-08-19
• Public Version: 1
• Public Version Date: 2025-08-27
• Public Version Status: New
• Public Device Record Key: 8a05c9af-6a86-4925-b19d-2847fe2b1e8b

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• 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
MCB	Antigen, C. Difficile	Microbiology	866.2660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
50832	Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from Clostridium difficile bacteria [e.g., glutamate dehydrogenase antigen (GDA), toxin A and/or toxin B] in a clinical specimen, using an enzyme immunoassay (EIA) method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08033891322748	GS1

Storage Conditions

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