Catalog Number

222291

Brand Name

BD Difco™ Neisseria Meningitidis Antiserum Group B

Version/Model Number

222291

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

GTJ

Product Code Name

ANTISERA, ALL GROUPS, N. MENINGITIDIS

Public Device Record Key

456e53eb-b325-475c-affe-80600f654ca4

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

April 28, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-