Catalog Number

HCDOAEC-6125S

Brand Name

Healgen

Version/Model Number

HCDOAEC-6125S

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

430de5e2-920c-4d64-bee0-5c8e6f4d8f5b

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

February 17, 2020

Package DI Number

10816490024375

Quantity per Package

25

Contains DI Package

00816490024378

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Pack