Catalog Number

DOA-3174-061

Brand Name

AYDMED Rapid Multi-Drug Test Dip Card

Version/Model Number

DOA-3174-061

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

March 01, 2032

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"

Yes

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

K131811,K131811,K131811

Product Code

DIO

Product Code Name

Enzyme Immunoassay, Cocaine And Cocaine Metabolites

Public Device Record Key

e55fa683-c99c-4d24-8871-def9f5bbdfbe

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

March 01, 2022

Package DI Number

20817038022096

Quantity per Package

150

Contains DI Package

10817038022099

Package Discontinue Date

March 01, 2032

Package Status

In Commercial Distribution

Package Type

case