Catalog Number

3459

Brand Name

Pneumococcus CWPS, 10 mg

Version/Model Number

3459

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

MVU

Product Code Name

Reagents, specific, analyte

Public Device Record Key

c469f1ae-01c9-43b4-add1-c8a7bce2bd1a

Public Version Date

August 02, 2021

Public Version Number

1

DI Record Publish Date

July 25, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-