MicroScan

GUDID 15099590659608

ESβL Plus ESBL Confirmation Panel

Beckman Coulter, Inc.

General-microorganism antimicrobial susceptibility culture medium IVD

• Primary Device ID: 15099590659608
• NIH Device Record Key: 670a1386-fe05-4088-a4ce-51e32fcfa58a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MicroScan
• Version Model Number: B1027-101
• Company DUNS: 008254708
• Company Name: Beckman Coulter, Inc.
• Device Count: 20
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05099590659601 [Unit of Use]
GS1	15099590659608 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020037

FDA Product Code

• LTT: Panels, Test, Susceptibility, Antimicrobial

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-02

On-Brand Devices [MicroScan]

• 15099590704117: Neg Urine Combo 88
• 15099590704100: Neg Urine Combo 87
• 15099590704094: Neg Urine Combo 86
• 15099590704087: Neg Urine Combo 85
• 15099590704070: Neg Urine Combo 84
• 15099590704063: Neg MIC 54
• 15099590704056: Neg MIC 53
• 15099590704049: Pos MIC 38
• 15099590704032: Pos Combo 46
• 15099590704025: Pos Combo 45
• 15099590703110: CD, Labpro V4.42 Panel Update-07 LabPro V4.42 Panel Update-07 Kit (US, OUS) LabPro V4.42 System
• 15099590699413: Detect Neg MIC 2
• 15099590693404: Detect Neg MIC Panel Type 1
• 15099590690892: DxM 1096 MicroScan Walkaway Instrument
• 15099590690885: DxM 1040 MicroScan WalkAway Instrument
• 15099590684099: LabPro Data Management System
• 15099590684082: LabPro Data Management System
• 15099590684068: LabPro Data Management System
• 1509959067712: LabPro-MBT System
• 15099590677831: LabPro Connect Data Management System
• 15099590677114: LabPro Data Management System
• 15099590659646: MICroSTREP Plus Panel Type 2
• 15099590659622: MICroSTREP Plus Panel Type 1
• 15099590659608: ESβL Plus ESBL Confirmation Panel
• 15099590658687: WalkAway-96 plus Instrument
• 15099590658663: WalkAway-40 plus Instrument
• 15099590658069: Neg Urine Combo Panel Type 79
• 15099590658052: Neg Urine Combo Panel Type 78
• 15099590658045: Neg Urine Combo Panel Type 77
• 15099590658038: Neg Urine Combo Panel Type 76
• 15099590658021: Neg Urine Combo Panel Type 75
• 15099590658014: Neg Urine Combo Panel Type 74
• 15099590658007: Neg MIC Panel Type 46
• 15099590657994: Neg MIC Panel Type 45
• 15099590657987: Neg Urine Combo Panel Type 73
• 15099590657970: Neg Combo Panel Type 68
• 15099590657963: Neg Combo Panel Type 67
• 15099590657956: Neg MIC Panel Type 43
• 15099590657949: Neg MIC Panel Type 42
• 15099590657932: Neg Breakpoint Combo Panel Type 47
• 15099590657925: Neg Urine Combo Panel Type 62
• 15099590657918: Neg Urine Combo Panel Type 61
• 15099590657901: Neg Urine Combo Panel Type 60
• 15099590657895: Neg MIC Panel Type 38
• 15099590657888: Neg Breakpoint Combo Panel Type 44
• 15099590657871: Neg Urine Combo Panel Type 55
• 15099590657864: Neg Breakpoint Combo Panel Type 41
• 15099590657857: Neg Urine Combo Panel Type 51
• 15099590657840: Neg Combo Panel Type 50
• 15099590657826: Neg BP Combo Panel Type 34