MicroScan (UDI B1015-2)
Manufactured by Beckman Coulter, Inc.
Device Regulatory Overview
The MicroScan (Model/Catalog Number: B1015-2) is a medical device manufactured by Beckman Coulter, Inc.. This product is indexed under FDA Product Code / Category Classification JSG within international Unique Device Identification (UDI) compliance databases.
Enforcement actions are currently active for this product line.
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MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with MicroScan Dried Gram Negative ...
Technical Specifications
- Model Number
- B1015-2
- Product Code / EMDN
- JSG
- Device Name
- MicroScan Inoculum Water - 3ml
- Database Sync Date
- 2026-08-09 09:22:51
Full Regulatory Attributes
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{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of MicroScan?
The registered manufacturer of record for MicroScan is Beckman Coulter, Inc..
What is the Primary UDI-DI identifier for MicroScan?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is B1015-2.
What classification code is assigned to this device?
This device is registered under product classification code JSG.
Similar Classification Devices (JSG)
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