Identity
- Trade Name
- MicroScan FDA UDI
- Generic Name
- Microorganism identification/antimicrobial-susceptibility analyser IVD FDA UDI
- Device Name
- LabPro Data Management System is a Microsoft® Windows based software program and is intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST) data generated from Beckman Coulter instruments or manually entered microbiology test results, for use by trained laboratory personnel. LabPro AlertEx is a functional subset of the LabPro Data Management System that analyzes Beckman Coulter ID and AST data, or other pre-defined parameters, against a series of established rules/ alerts and notifies the user of unusual, and/or critical conditions, which may warrant further analysis or action. FDA UDI
- Model / Reference
- V5.0 FDA UDI
- Description
- LabPro Data Management System is a Microsoft® Windows based software program and is intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST) data generated from Beckman Coulter instruments or manually entered microbiology test results, for use by trained laboratory personnel. LabPro AlertEx is a functional subset of the LabPro Data Management System that analyzes Beckman Coulter ID and AST data, or other pre-defined parameters, against a series of established rules/ alerts and notifies the user of unusual, and/or critical conditions, which may warrant further analysis or action. FDA UDI
Identifiers
- Catalog Number
- C24145 FDA UDI
- Primary DI / UDI-DI
- 15099590702717 FDA UDI
- 510(k) Number
- K201405 FDA UDI
- FDA Product Code
- LON FDA UDI
- GMDN Term
- Microorganism identification/antimicrobial-susceptibility analyser IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.1645 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Microorganism identification/antimicrobial-susceptibility analyser IVD
MicroScan by Beckman Coulter, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K201405 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Beckman Coulter, Inc.
Sources (1)
- FDA UDI 404ea4ec-68f7-4990-a68f-7908bf6c780b 35 fields · synced Jun 8, 2026