Catalog Number

96844

Brand Name

Pneumococcus Factor 15e serum high titer, 1 mL

Version/Model Number

96844

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

1e1213f3-682f-4fd3-80bd-ae0dcc933afb

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

-