Catalog Number

HDOA-254A3

Brand Name

Healgen

Version/Model Number

HDOA-254A3

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)

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

DIO

Product Code Name

Enzyme Immunoassay, Cocaine And Cocaine Metabolites

Public Device Record Key

ffdc9998-62f4-42df-85d2-3b6f0e2d86ea

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

February 18, 2017

Package DI Number

20816490020435

Quantity per Package

20

Contains DI Package

10816490020438

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case