Catalog Number

-

Brand Name

ROM Plus® Strip Quality Control

Version/Model Number

ROM-QCS

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"

Yes

For Single-Use

Yes

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

K110605,K110605,K110605

Product Code

JJX

Product Code Name

Single (Specified) Analyte Controls (Assayed And Unassayed)

Public Device Record Key

23124eb6-a7a1-4fb7-95e1-0fc54a86c31d

Public Version Date

November 19, 2020

Public Version Number

4

DI Record Publish Date

September 01, 2016

Package DI Number

20814247020462

Quantity per Package

6

Contains DI Package

10814247020465

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-