MicroScan

Basic Information

• Brand Name: MicroScan
• Primary DI: 15099590655402
• Version / Model: B1012-10B
• Company Name: Beckman Coulter, Inc.
• Labeler DUNS: 008254708
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2022-12-05
• Public Version: 1
• Public Version Date: 2022-12-13
• Public Version Status: New
• Public Device Record Key: cab572c6-21cd-4397-84cd-20f6d231fb70

Device Description

MicroScan HNID Panel

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
LQM	Gram Negative Identification Panel	Microbiology	866.2660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
50417	Multiple gram negative bacteria 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 gram negative bacteria belonging to the Enterobacteriaceae or non-Enterobacteriaceae families, that have been isolated by culture from a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	15099590655402	GS1
Unit of Use	05099590655405	GS1