Catalog Number

221301

Brand Name

BD Difco™ QC Antigen Salmonella O Group A

Version/Model Number

221301

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

GRL

Product Code Name

ANTIGENS, ALL GROUPS, SALMONELLA SPP.

Public Device Record Key

d0d9e186-ad3e-481d-91fc-513c052793ef

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

-