MicroScan

Basic Information

• Brand Name: MicroScan
• Primary DI: 15099590658663
• Version / Model: B1018-283
• Company Name: Beckman Coulter, Inc.
• Labeler DUNS: 008254708
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 4
• Public Version Date: 2022-09-16
• Public Version Status: Update
• Public Device Record Key: 73636348-6c36-42aa-bf36-52584b7a4441

Device Description

WalkAway-40 plus Instrument

Device Characteristics

• Single Use: No
• 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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LRG	Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems	Microbiology	866.1640	2

GMDN Terms

Code	Name	Definition	Implantable	Status
56747	Microorganism identification/antimicrobial-susceptibility analyser IVD	An electrically-powered automated or semi-automated laboratory instrument intended to be used for the identification of bacteria and/or yeast isolated from clinical specimens and for the determination of their antimicrobial susceptibility profile using morphology, substrate utilization and/or biochemical reactivity and by monitoring growth rates and/or determining endpoint growth, against a range of antimicrobials. Growth detection technology used may include immunoassay, colorimetry, fluorimetry, chromatography and/or carbon dioxide production.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	15099590658663	GS1