BD Difco™ Shigella Antiserum Poly Group C1 - BD Difco™ Shigella Antiserum Poly Group C1 - BECTON, DICKINSON AND COMPANY

Duns Number:122561087

Device Description: BD Difco™ Shigella Antiserum Poly Group C1

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More Product Details

Catalog Number

227771

Brand Name

BD Difco™ Shigella Antiserum Poly Group C1

Version/Model Number

227771

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

GNB

Product Code Name

ANTISERA, ALL TYPES, SHIGELLA SPP.

Device Record Status

Public Device Record Key

ad106c6f-3caf-4d66-8cf6-1300d488b0d5

Public Version Date

January 22, 2021

Public Version Number

3

DI Record Publish Date

April 29, 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