Catalog Number

ABCard-01-OPI2000

Brand Name

Advin Multi-Drug Screen Test

Version/Model Number

1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

July 31, 2030

Issuing Agency

In HIBCC

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K122809,K122809

Product Code

DJG

Product Code Name

Enzyme Immunoassay, Opiates

Public Device Record Key

da686f74-2d95-4625-a1bf-9d3d8d32f6b1

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

August 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-