ProSpecT

Basic Information

• Brand Name: ProSpecT
• Primary DI: 05032384519903
• Version / Model: R244596
• Catalog Number: R244596
• Company Name: REMEL, INC.
• Labeler DUNS: 065769564
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-23
• Public Version: 1
• Public Version Date: 2023-01-02
• Public Version Status: New
• Public Device Record Key: 0fc963b4-5202-4fd3-af19-0c92dfdd6d9d

Device Description

ProSpecT C. diff Toxin A/B MP KT/96TST

Device Characteristics

• Single Use: No
• 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: Yes
• 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
LLH	Reagents, Clostridium Difficile Toxin	Microbiology	866.2660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
66472	Bacterial species differentiation disc IVD	One or multiple diagnostic discs impregnated with an antibacterial/antibiotic agent (i.e., a drug intended for treatment and/or prevention of a bacterial infection) or microbial test reagent, intended to be used for the presumptive identification of a bacterial specie(s) [excluding mycobateria] isolated from a clinical specimen by culture, based on specific characteristics (e.g., antibiotic resistance, ability to utilize and/or synthesize specific metabolites).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05032384519903	GS1