Identity
- Trade Name
- MicroScan FDA UDI
- Generic Name
- Microorganism identification/antimicrobial-susceptibility analyser IVD FDA UDI
- Device Name
- LabPro V5.0 Panel Update 10 (US), Electronic - C90679; DVD, LabPro V5.0 Panel Update 10 (US) - C90680 FDA UDI
- Model / Reference
- V5.00 FDA UDI
- Description
- LabPro V5.0 Panel Update 10 (US), Electronic - C90679; DVD, LabPro V5.0 Panel Update 10 (US) - C90680 FDA UDI
Identifiers
- Catalog Number
- C90679, C90680 FDA UDI
- Primary DI / UDI-DI
- 15099590772741 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
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 167ff431-fe4e-4ca0-a2d3-3478b445af2e 35 fields · synced Jun 8, 2026