Catalog Number

CM-190

Brand Name

Oratect Oral Fluid Collection Tube

Version/Model Number

CM-190

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 01, 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

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

K103227

Product Code

DIO

Product Code Name

Enzyme Immunoassay, Cocaine And Cocaine Metabolites

Public Device Record Key

e8aaf453-7b5d-41ba-97f2-35989cade4db

Public Version Date

July 22, 2021

Public Version Number

5

DI Record Publish Date

July 29, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-