Catalog Number

-

Brand Name

RIGHTEST GT333 Control Solution

Version/Model Number

Level 2

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

-

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

-

Product Code

JJX

Product Code Name

Single (Specified) Analyte Controls (Assayed And Unassayed)

Public Device Record Key

aef117fd-0c22-446d-a06b-fbf4e36a309f

Public Version Date

October 16, 2019

Public Version Number

1

DI Record Publish Date

October 08, 2019

Package DI Number

20883489001935

Quantity per Package

6

Contains DI Package

10883489001938

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

paper