Catalog Number

07RD7011

Brand Name

QuickProfile™ Opiate Test Strip

Version/Model Number

07RD7011

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)

Yes

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

eb60523f-c14b-425e-908e-b492ada54647

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

November 15, 2017

Package DI Number

M90107RD70111

Quantity per Package

50

Contains DI Package

M90107RD70110

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK