Catalog Number

-

Brand Name

co-innovation

Version/Model Number

OPI Test Strip

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 27, 2017

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

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

PVH

Product Code Name

Test, Opiates, Employment And Insurance Testing, Exempt

Public Device Record Key

e16531a9-608a-4d45-850a-9150eb1ee501

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

September 27, 2017

Package DI Number

06970429840430

Quantity per Package

100

Contains DI Package

06970429840423

Package Discontinue Date

September 25, 2017

Package Status

Not in Commercial Distribution

Package Type

-