Rapid Response - Rapid Response 5-Test Integrated Cup (5.1) - COC - BTNX Inc

Duns Number:251005005

Device Description: Rapid Response 5-Test Integrated Cup (5.1) - COC AMP MET THC OPI

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Rapid Response

Version/Model Number

D5.1-1G29

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K161044

Product Code Details

Product Code

DIO

Product Code Name

Enzyme Immunoassay, Cocaine And Cocaine Metabolites

Device Record Status

Public Device Record Key

f4725192-07e1-42ee-811b-505bb4922889

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

February 07, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BTNX INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 27