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Roma

FDA UDI

Class II (US FDA UDI)

by Fujirebio Diagnostics, Inc.

Identity

Trade Name
ROMA FDA UDI
Generic Name
Laboratory instrument/analyser application software IVD FDA UDI
Device Name
ROMA (HE4 EIA + ARCHITECT CA125II) Software disk FDA UDI
Model / Reference
404-10US FDA UDI
Description
ROMA (HE4 EIA + ARCHITECT CA125II) Software disk FDA UDI

Identifiers

Primary DI / UDI-DI
00869164000024 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

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 3fc2e098-063a-4821-8ce9-07d7c013dedb 35 fields · synced Jun 9, 2026