Catalog Number

UCC-12-1M

Brand Name

National Test Systems

Version/Model Number

UCC-12-1M

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K151213,K151213,K151213

Product Code

DIO

Product Code Name

Enzyme Immunoassay, Cocaine And Cocaine Metabolites

Public Device Record Key

68d72653-8c2f-41ba-be80-6e2a97c96ff6

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

January 20, 2017

Package DI Number

20817038021747

Quantity per Package

8

Contains DI Package

10817038021740

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case