Catalog Number

71130-3

Brand Name

DrugCheck

Version/Model Number

71130-3

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

DJG

Product Code Name

Enzyme Immunoassay, Opiates

Public Device Record Key

503c2f24-4c0f-460b-a441-3dc3c5c9e0e3

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

March 05, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-