Catalog Number

-

Brand Name

PreChek Multi-Drug Test Square Cup

Version/Model Number

IDOA-7325SC-25P

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)

-

Kit

-

Combination Product

Yes

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

e41bff07-8e72-45a2-86f4-3620b99ce997

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

June 20, 2018

Package DI Number

00857275007094

Quantity per Package

25

Contains DI Package

00857275007285

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box