Catalog Number

80502-OD-EI

Brand Name

Origin Instant Oral Drug Test

Version/Model Number

80502-OD-EI

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

PUX

Product Code Name

Test, Amphetamine, Employment And Insurance Testing, Exempt

Public Device Record Key

a65ddd9c-9934-4c91-be12-5bed270e5013

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

January 24, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-