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Lumipulse G ROMA

FDA UDI

Class II (US FDA UDI)

by Fujirebio Diagnostics, Inc.

Identity

Trade Name
Lumipulse G ROMA FDA UDI
Generic Name
Laboratory instrument/analyser application software IVD FDA UDI
Device Name
Software Disk FDA UDI
Model / Reference
CL0004 FDA UDI
Description
Software Disk FDA UDI

Identifiers

Primary DI / UDI-DI
00869164000017 FDA UDI
510(k) Number
K160090 FDA UDI
FDA Product Code
ONX FDA UDI
GMDN Term
Laboratory instrument/analyser application software IVD FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.6050 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

No

FDA UDI

Category: Laboratory instrument/analyser application software IVD

Lumipulse G ROMA by Fujirebio Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Laboratory instrument/analyser application software IVD.

Cleared under the same submission

K160090 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Fujirebio Diagnostics, Inc.

Sources (1)

  • FDA UDI c9822222-c641-4a3b-9e7e-2546cecacd47 35 fields · synced Jun 9, 2026