NA

Basic Information

• Brand Name: NA
• Primary DI: 00848838091827
• Version / Model: 7115-60
• Company Name: REMEL, INC.
• Labeler DUNS: 065769564
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 80
• Record Status: Published
• Publish Date: 2022-04-21
• Public Version: 2
• Public Version Date: 2026-02-04
• Public Version Status: Update
• Public Device Record Key: 11f17eed-ea71-4756-87fd-b6bdd7b4eabc
• Distribution End Date: 2025-08-04

Device Description

VERSATREK MYCO SUSCEPTIBILITY KIT

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
MDB	System, Blood Culturing	Microbiology	866.2560	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58687	Enriched broth culture medium IVD	A broth culture medium supplemented with nutrient-rich substances (e.g., blood, serum) intended to enhance the growth and isolation of fastidious microorganisms, from a clinical specimen and/or culture isolate. It is typically used to cultivate microorganisms that would not otherwise grow in a general-purpose broth medium.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	30848838091828	GS1
Primary	00848838091827	GS1

Customer Contacts

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