Catalog Number

DCT-102

Brand Name

Cotinine (COT) Rapid Test Cassette

Version/Model Number

DCT-102

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

MRS

Product Code Name

Test System, Nicotine, Cotinine, Metabolites

Public Device Record Key

655f5020-d659-44ef-b1df-818c3bf5a28e

Public Version Date

October 09, 2018

Public Version Number

1

DI Record Publish Date

September 08, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-