Catalog Number

U-AMP-101

Brand Name

UCP Home Drug Screening Test Strips

Version/Model Number

U-AMP-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"

Yes

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

K050540,K050540,K050540

Product Code

DKZ

Product Code Name

Enzyme Immunoassay, Amphetamine

Public Device Record Key

b708741d-e2ea-414a-bf41-c4e898efa9af

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

January 31, 2019

Package DI Number

20817038021983

Quantity per Package

40

Contains DI Package

10817038021986

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case