Toxigenic C. difficile Direct Test - Sample Prep

Basic Information

• Brand Name: Toxigenic C. difficile Direct Test - Sample Prep
• Primary DI: G491CDF2SPD0
• Version / Model: 00
• Catalog Number: CDF2-SPD
• Company Name: Vela Operations USA Inc.
• Labeler DUNS: 117416922
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-01-18
• Public Version: 1
• Public Version Date: 2024-01-26
• Public Version Status: New
• Public Device Record Key: 558d79a6-14a1-4eef-9f46-8a441c2601f7

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
OZN	C. Difficile Toxin Gene Amplification Assay	Microbiology	866.3130	2

GMDN Terms

Code	Name	Definition	Implantable	Status
50836	Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid, including specific gene markers from Clostridium difficile bacteria in a clinical specimen and/or culture isolate, using a nucleic acid technique (NAT). Markers detected may include genes conferring antimicrobial resistance (e.g., gyrA gene), virulence (e.g., ribotype 027) and genes encoding toxin A and/or B.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	G491CDF2SPD0	HIBCC

Customer Contacts

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