BD Difco™ QC Antigen Salmonella O Group H - Vial Qc Antigen Salmonella O Grp H 1Ml - BECTON, DICKINSON AND COMPANY

Duns Number:122561087

Device Description: Vial Qc Antigen Salmonella O Grp H 1Ml

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More Product Details

Catalog Number

221401

Brand Name

BD Difco™ QC Antigen Salmonella O Group H

Version/Model Number

221401

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 29, 2021

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

GRL

Product Code Name

ANTIGENS, ALL GROUPS, SALMONELLA SPP.

Device Record Status

Public Device Record Key

2f07dc0c-7406-4a14-bf65-f72bf18db05c

Public Version Date

July 15, 2022

Public Version Number

3

DI Record Publish Date

April 28, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BECTON, DICKINSON AND COMPANY" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 611
2 A medical device with a moderate to high risk that requires special controls. 614
3 A medical device with high risk that requires premarket approval 36
U Unclassified 4