Catalog Number

RC10TCA

Brand Name

RealityCHECK Drugs of Abuse Cup

Version/Model Number

RC10TCA

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 02, 2017

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

DIO

Product Code Name

Enzyme Immunoassay, Cocaine And Cocaine Metabolites

Public Device Record Key

ecb69973-53dc-49bd-bdfa-4d5204bd0244

Public Version Date

June 10, 2022

Public Version Number

6

DI Record Publish Date

October 20, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-