Catalog Number

07RD7018

Brand Name

QuickProfile™ Benzodiazepine Test Card

Version/Model Number

07RD7018

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

JXM

Product Code Name

Enzyme Immunoassay, Benzodiazepine

Public Device Record Key

05257d57-c2c4-4cbc-ad6d-d61104cc025d

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

November 15, 2017

Package DI Number

M90107RD70181

Quantity per Package

25

Contains DI Package

M90107RD70180

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK