Catalog Number

HDOA-1864

Brand Name

Healgen

Version/Model Number

HDOA-1864

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

31ee71c3-e9e1-4610-81d7-fd4221380d54

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

August 12, 2019

Package DI Number

20816490023634

Quantity per Package

20

Contains DI Package

10816490023637

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case