Catalog Number

98928

Brand Name

ImmuLex Pneumococcus Factor 15h, 1.5 mL

Version/Model Number

98928

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

GWC

Product Code Name

ANTISERA, ALL TYPES, STREPTOCOCCUS PNEUMONIAE

Public Device Record Key

47621a21-5bb3-41c5-8445-f6dde9d9e52b

Public Version Date

August 09, 2021

Public Version Number

1

DI Record Publish Date

August 01, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-