AccessGUDID - DEVICE: BD Difco™ QC Antigen Shigella Group C (00382902210313)

GUDID

Device Identifier (DI) Information

Brand Name: BD Difco™ QC Antigen Shigella Group C
Version or Model: 221031
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 221031
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 00382902210313
Issuing Agency: GS1
Commercial Distribution End Date: July 15, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: Vial Qc Antigen Shigella Grp C 1Ml

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?
51602	Multiple Shigella species culture isolate antigen IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative detection of antigens from one or multiple species of Shigella bacteria isolated by culture from a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LIA	ANTIGENS, ALL GROUPS, SHIGELLA 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
Total Volume: 1 Milliliter

Device Record Status

Public Device Record Key: 6e1297f6-9690-4888-8b7a-9665bbc5cc29
Public Version Date: June 12, 2023
Public Version Number: 3
DI Record Publish Date: April 28, 2016