Catalog Number

66442

Brand Name

Shigella dysentariae pool serum, 3 mL

Version/Model Number

66442

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 16, 2021

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

GNB

Product Code Name

Antisera, All Types, Shigella Spp.

Public Device Record Key

6db81a38-590c-43b3-b046-c62c761ac3a4

Public Version Date

June 17, 2021

Public Version Number

4

DI Record Publish Date

September 13, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-