Catalog Number

30110

Brand Name

DrugCheck

Version/Model Number

30110

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

K142353

Product Code

DKZ

Product Code Name

Enzyme Immunoassay, Amphetamine

Public Device Record Key

c2b9d36d-4aee-4f65-8477-60e7c4401ee8

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

April 08, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-