AccessGUDID - DEVICE: BD Difco™ Escherichia coli O Antiserum O157 (00382902297017)

GUDID

Device Identifier (DI) Information

Brand Name: BD Difco™ Escherichia coli O Antiserum O157
Version or Model: 229701
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 229701
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 00382902297017
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: Difco™ E. Coli O Antiserum O157

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?
50913	Escherichia coli antigen IVD, kit, agglutination	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from Escherichia coli (E. coli) bacteria in a clinical specimen and/or culture isolate, using an agglutination method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GNA	ANTISERA, ALL TYPES, ESCHERICHIA COLI

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: 3 Milliliter

Device Record Status

Public Device Record Key: 23526fb1-52fb-4fa3-867f-7a765d8feb78
Public Version Date: June 28, 2024
Public Version Number: 3
DI Record Publish Date: May 25, 2018