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MicroScan

FDA UDI

Class II (US FDA UDI)

by Beckman Coulter, Inc.

Identity

Trade Name
MicroScan FDA UDI
Generic Name
Microorganism identification/antimicrobial-susceptibility analyser IVD FDA UDI
Device Name
LabPro-MBT software is a functional subset of LPDMS intended to electronically transfer and display organism identifications from the Bruker MALDI Biotyper System to the LabPro Data Management System. LabPro-MBT software is a device that is intended to electronically transfer medical device data, without controlling or altering the functions or parameters of any connected medical devices. FDA UDI
Model / Reference
V3.0 FDA UDI
Description
LabPro-MBT software is a functional subset of LPDMS intended to electronically transfer and display organism identifications from the Bruker MALDI Biotyper System to the LabPro Data Management System. LabPro-MBT software is a device that is intended to electronically transfer medical device data, without controlling or altering the functions or parameters of any connected medical devices. FDA UDI

Identifiers

Catalog Number
C24160 FDA UDI
Primary DI / UDI-DI
15099590702779 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

Similar devices

Also classified as Microorganism identification/antimicrobial-susceptibility analyser IVD.

Cleared under the same submission

K201405 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Beckman Coulter, Inc.

Sources (1)

  • FDA UDI 2027c555-08c8-4d24-9291-9025ae1e4764 35 fields · synced Jun 8, 2026