Catalog Number

-

Brand Name

PreKnow

Version/Model Number

21115061010308-B

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

K153050,K153050

Product Code

DIO

Product Code Name

Enzyme Immunoassay, Cocaine And Cocaine Metabolites

Public Device Record Key

046444c9-5ad6-4ff5-b031-5f646941878b

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

August 02, 2018

Package DI Number

00857275007438

Quantity per Package

25

Contains DI Package

00857275007537

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box