Remel

Basic Information

• Brand Name: Remel
• Primary DI: 00848838028779
• Version / Model: R30851401
• Company Name: REMEL, INC.
• Labeler DUNS: 065769564
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2022-04-21
• Public Version: 1
• Public Version Date: 2022-04-29
• Public Version Status: New
• Public Device Record Key: be594ac7-57be-4aca-9383-6386615256fc

Device Description

Candida albicans screen 50TST/KT

Device Characteristics

• Single Use: Yes
• 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
JXC	Kit, Screening, Yeast	Microbiology	866.2660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
30666	Multiple Candida/yeast species culture isolate identification IVD, kit	A collection of reagents and other associated materials intended to be used for the differentiation and/or identification of one or multiple species of Candida and/or yeast isolated by culture from a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	30848838028770	GS1
Primary	00848838028779	GS1

Customer Contacts

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