Catalog Number

30110

Brand Name

DrugCheck

Version/Model Number

30110

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 26, 2019

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

DKZ

Product Code Name

Enzyme Immunoassay, Amphetamine

Public Device Record Key

d8ef1e10-4962-42d6-93af-7316be5b275d

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

August 31, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-