Catalog Number

TNR CDOA5125A3

Brand Name

BluRapids™

Version/Model Number

TNR CDOA5125A3

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K153050,K153050,K153050

Product Code

DIO

Product Code Name

Enzyme Immunoassay, Cocaine And Cocaine Metabolites

Public Device Record Key

3efeb0dd-7998-4602-a343-b9a79783dc5e

Public Version Date

June 10, 2022

Public Version Number

6

DI Record Publish Date

August 15, 2016

Package DI Number

10850011007072

Quantity per Package

25

Contains DI Package

00850011007075

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Pack