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ROMA Calculation Tool Using Elecsys Assay

FDA UDI

Class II (US FDA UDI)

by Roche Diagnostics Corp.

Identity

Trade Name
ROMA Calculation Tool Using Elecsys Assay FDA UDI
Generic Name
Medical equipment clinical data interfacing software FDA UDI
Model / Reference
07113358001 FDA UDI

Identifiers

Catalog Number
07113358001 FDA UDI
Primary DI / UDI-DI
00365702702127 FDA UDI
510(k) Number
K153607 FDA UDI
FDA Product Code
ONX FDA UDI
GMDN Term
Medical equipment clinical data interfacing software 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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Medical equipment clinical data interfacing software

ROMA Calculation Tool Using Elecsys Assay by Roche Diagnostics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Medical equipment clinical data interfacing software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Roche Diagnostics Corp.

Sources (1)

  • FDA UDI dc4533b4-1c65-4f8a-97f2-44ea0a9a8d6a 34 fields · synced Jun 1, 2026