Catalog Number

HDTH-101

Brand Name

Healgen

Version/Model Number

HDTH-101

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

94dc7fff-b4b7-431c-a1a4-974f3f812677

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

February 18, 2017

Package DI Number

20816490020305

Quantity per Package

50

Contains DI Package

10816490020308

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case