Catalog Number

BC17S

Brand Name

Monitect Drug Screen Cassette Test

Version/Model Number

BC17S

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 10, 2016

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

-

Product Code

DIS

Product Code Name

Enzyme Immunoassay, Barbiturate

Public Device Record Key

ae392bb3-fc5c-49ed-a12e-ae7a881f0b98

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

August 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-