Catalog Number

294050

Brand Name

NA

Version/Model Number

294050

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 31, 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

41ee966f-489a-4db4-9814-5ce24b045ce2

Public Version Date

August 31, 2018

Public Version Number

3

DI Record Publish Date

September 17, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-