Catalog Number

990310

Brand Name

Prodigy Control Solution Low

Version/Model Number

990310

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

ceb92e59-c06d-42e1-bdcc-1153217fb631

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 22, 2016

Package DI Number

00384842903102

Quantity per Package

1000

Contains DI Package

00384849903105

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Corrugated Carton