Remel

Basic Information

• Brand Name: Remel
• Primary DI: 00848838058110
• Version / Model: R8311004
• Company Name: REMEL, INC.
• Labeler DUNS: 065769564
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2021-11-12
• Public Version: 2
• Public Version Date: 2021-12-08
• Public Version Status: Update
• Public Device Record Key: fa527fa1-4538-4476-8ead-df1ee35d489f

Device Description

RapID SS/u System KT/20

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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
JSS	Kit, Identification, Enterobacteriaceae	Microbiology	866.2660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62908	Multiple urinary tract pathogen culture isolate identification IVD, kit, rapid	A collection of reagents and other associated materials intended to be used for the differentiation and/or identification of one or multiple pathogens associated with urinary tract infection, isolated by culture from a clinical specimen, and requiring less incubation time than standard laboratory methods. Organisms may include (but are not limited to) Escherichia coli, Proteus mirabilis, Klebsiella, Staphylococcus aureus, and Candida albicans.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	30848838058111	GS1
Primary	00848838058110	GS1

Customer Contacts

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