Catalog Number

-

Brand Name

AICARE

Version/Model Number

Multi Drug Screen Test

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 18, 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

Product Code

DIO

Product Code Name

Enzyme Immunoassay, Cocaine And Cocaine Metabolites

Public Device Record Key

298a5c4c-9205-48e6-83ad-03baaae917eb

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

March 18, 2019

Package DI Number

26970429840571

Quantity per Package

10

Contains DI Package

06970429840577

Package Discontinue Date

March 18, 2019

Package Status

Not in Commercial Distribution

Package Type

-