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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
DVD, LabPro V5.00 Data Delivery-01 (US, FMR) FDA UDI
Model / Reference
V5.00 FDA UDI
Description
DVD, LabPro V5.00 Data Delivery-01 (US, FMR) FDA UDI

Identifiers

Catalog Number
C62574 FDA UDI
Primary DI / UDI-DI
15099590738884 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

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 7795f1a4-2e94-47c4-b8af-98808f41ecab 35 fields · synced Jun 8, 2026