Catalog Number

-

Brand Name

Preview

Version/Model Number

PRE-PDOA-9135A3

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)

Yes

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K133968,K133968,K152495,K152495,K133968,K152495

Product Code

DIO

Product Code Name

Enzyme Immunoassay, Cocaine And Cocaine Metabolites

Public Device Record Key

dd34a441-4e4d-4497-9846-032acfd88cd8

Public Version Date

October 31, 2022

Public Version Number

4

DI Record Publish Date

December 22, 2019

Package DI Number

10816862021780

Quantity per Package

4

Contains DI Package

00816862021783

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-