Catalog Number

-

Brand Name

Quick Test

Version/Model Number

1.0

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,K153050,K153050,K153050,K153050,K153050,K153050,K153050

Product Code

DIO

Product Code Name

Enzyme Immunoassay, Cocaine And Cocaine Metabolites

Public Device Record Key

05b70596-6a1d-486d-9779-a2b9909938bd

Public Version Date

June 10, 2022

Public Version Number

6

DI Record Publish Date

February 22, 2018

Package DI Number

20863451000425

Quantity per Package

6

Contains DI Package

00863451000421

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper Display Tray