MicroScan

Basic Information

• Brand Name: MicroScan
• Primary DI: 15099590659608
• Version / Model: B1027-101
• Company Name: Beckman Coulter, Inc.
• Labeler DUNS: 008254708
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2016-09-02
• Public Version: 4
• Public Version Date: 2023-11-20
• Public Version Status: Update
• Public Device Record Key: 670a1386-fe05-4088-a4ce-51e32fcfa58a

Device Description

ESBL Plus ESBL Confirmation 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: 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
LTT	Panels, Test, Susceptibility, Antimicrobial	Microbiology	866.1640	2
LRG	Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems	Microbiology	866.1640	2
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	866.1640	2
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	866.1640	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58605	General-microorganism antimicrobial susceptibility culture medium IVD	A non-selective culture medium intended to be used to perform diagnostic antimicrobial susceptibility testing on general microorganisms isolated from a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	15099590659608	GS1
Unit of Use	05099590659601	GS1

Premarket Submissions

Submission Number	Supplement Number
K020037	000
K061536	000
K192355	000
K201423	000
K202343	000
K862140	000
K863776	000
K870074	000
K941030	000
K962150	000
K971376	000