Catalog Number

294418

Brand Name

NA

Version/Model Number

294418

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

GRM

Product Code Name

Antisera, All Groups, Salmonella Spp.

Public Device Record Key

2c4bb9b0-0f93-45d2-bb8c-5e3e1fa0010c

Public Version Date

March 31, 2020

Public Version Number

3

DI Record Publish Date

October 23, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-