Catalog Number

-

Brand Name

Rapid Response

Version/Model Number

04GLU-49

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)

Yes

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K063212

Product Code

CGA

Product Code Name

Glucose Oxidase, Glucose

Public Device Record Key

4a631d0b-2a30-451f-9b4d-36e9b7a8192a

Public Version Date

June 03, 2021

Public Version Number

2

DI Record Publish Date

February 05, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-