Catalog Number

-

Brand Name

QTEST

Version/Model Number

1

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 15, 2018

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

f9e370d9-03e6-4993-a204-dd982500b0a5

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

June 11, 2018

Package DI Number

26970429840564

Quantity per Package

12

Contains DI Package

16970429840567

Package Discontinue Date

June 11, 2018

Package Status

Not in Commercial Distribution

Package Type

-