AccessGUDID - DEVICE: BD Difco™ Salmonella O Antiserum Group N Factor 30 (00382902117834)

GUDID

Device Identifier (DI) Information

Brand Name: BD Difco™ Salmonella O Antiserum Group N Factor 30
Version or Model: 211783
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 211783
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 00382902117834
Issuing Agency: GS1
Commercial Distribution End Date: June 29, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: BD Difco™ Salmonella O Antiserum Group N Factor 30

Device Characteristics

What MRI safety information does the labeling contain?	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":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
51520	Multiple Salmonella species antigen IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of antigens from one or multiple species of Salmonella bacteria in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GRM	ANTISERA, ALL GROUPS, SALMONELLA SPP.

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2e748c6d-8397-47a7-a294-4bbd1a4017f0
Public Version Date: February 12, 2024
Public Version Number: 4
DI Record Publish Date: April 28, 2016