Catalog Number

CC413

Brand Name

CAROLINA LIQUID CHEMISTRIES CORP.® COCM COCAINE CC413

Version/Model Number

CC413

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 27, 2018

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

-

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

-

Product Code

DIO

Product Code Name

ENZYME IMMUNOASSAY, COCAINE AND COCAINE METABOLITES

Public Device Record Key

eba0d41e-a134-4cab-870a-d4144a0bfe5c

Public Version Date

August 28, 2018

Public Version Number

3

DI Record Publish Date

September 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-