Catalog Number

-

Brand Name

Status Toxi Cup 13+4

Version/Model Number

65C12+4

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 01, 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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K130275,K071489,K130275,K122064,K071489,K122064,K130275,K071489,K122064

Product Code

DIO

Product Code Name

Enzyme Immunoassay, Cocaine And Cocaine Metabolites

Public Device Record Key

e6714c35-5419-43ff-8eea-02e12413aee8

Public Version Date

March 26, 2020

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

20863480002117

Quantity per Package

4

Contains DI Package

10863480002110

Package Discontinue Date

June 01, 2017

Package Status

Not in Commercial Distribution

Package Type

Shipper Box