Catalog Number

07113358001

Brand Name

ROMA Calculation Tool Using Elecsys Assay

Version/Model Number

07113358001

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K153607

Product Code

ONX

Product Code Name

ovarian adnexal mass assessment score test system

Public Device Record Key

dc4533b4-1c65-4f8a-97f2-44ea0a9a8d6a

Public Version Date

November 08, 2018

Public Version Number

4

DI Record Publish Date

October 28, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-