Catalog Number

MER HCDOAY6125

Brand Name

Platinum+

Version/Model Number

MER HCDOAY6125

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

DIO

Product Code Name

Enzyme Immunoassay, Cocaine And Cocaine Metabolites

Public Device Record Key

8e326bff-4c73-4888-9cbe-260ac4214758

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

March 30, 2018

Package DI Number

00850011007334

Quantity per Package

4

Contains DI Package

00850011007327

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case