Catalog Number

295194

Brand Name

NA

Version/Model Number

295194

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 25, 2018

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

GNB

Product Code Name

Antisera, All Types, Shigella Spp.

Public Device Record Key

8cf8a809-5723-4398-850b-b17957b4658d

Public Version Date

January 22, 2021

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-