Catalog Number

-

Brand Name

11Pannel drug test cup

Version/Model Number

11Pannel drug test cup

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 04, 2019

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)

Yes

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

f5cda88f-c5bd-4251-9e00-8d56ed605ad9

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

October 28, 2019

Package DI Number

26970429841127

Quantity per Package

210

Contains DI Package

06970429841123

Package Discontinue Date

November 04, 2019

Package Status

Not in Commercial Distribution

Package Type

-