Identity
- Trade Name
- MicroScan FDA UDI
- Generic Name
- Microorganism identification/antimicrobial-susceptibility analyser IVD FDA UDI
- Device Name
- LabPro Connect software is an option for laboratories with multiple instruments and workstations in a networked environment to improve workflow efficiency, data processing and storage, and to increase throughput. With LabPro Connect software, you can access all results data from any MicroScan instrument on the LabPro network and perform most daily tasks (for example, ordering panels, printing barcode labels, viewing panel results, resolving panel processing alerts, and transmitting test results). FDA UDI
- Model / Reference
- V5.0 FDA UDI
- Description
- LabPro Connect software is an option for laboratories with multiple instruments and workstations in a networked environment to improve workflow efficiency, data processing and storage, and to increase throughput. With LabPro Connect software, you can access all results data from any MicroScan instrument on the LabPro network and perform most daily tasks (for example, ordering panels, printing barcode labels, viewing panel results, resolving panel processing alerts, and transmitting test results). FDA UDI
Identifiers
- Catalog Number
- C24147 FDA UDI
- Primary DI / UDI-DI
- 15099590702724 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 227214b6-dad0-4cec-92ec-81ba9ecee641 35 fields · synced Jun 8, 2026