Catalog Number

-

Brand Name

Rapid Response

Version/Model Number

D12.5-1V

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

K180349,K180349,K180349

Product Code

NFT

Product Code Name

Test, Amphetamine, Over The Counter

Public Device Record Key

c3a99d6f-cd61-4b52-8c5a-4edd6b21fa58

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

January 21, 2019

Package DI Number

17220660045481

Quantity per Package

6

Contains DI Package

00722066004548

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-