Catalog Number

ID-H12-2

Brand Name

Identify Health

Version/Model Number

ID-H12-2

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 08, 2020

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K122809,K122809

Product Code

DIO

Product Code Name

Enzyme Immunoassay, Cocaine And Cocaine Metabolites

Public Device Record Key

aaa7b2ea-86e4-450a-b413-c83c1dd120bb

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

August 26, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-