AccessGUDID - DEVICE: ProSpecT C. difficile Toxin A/B Microplate (05032384519903)

GUDID

Device Identifier (DI) Information

Brand Name: ProSpecT C. difficile Toxin A/B Microplate
Version or Model: R244596
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: OXOID LIMITED

Primary DI Number: 05032384519903
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 365355452 *Terms of Use

Device Description: No description.

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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
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?
50832	Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from Clostridium difficile bacteria [e.g., glutamate dehydrogenase antigen (GDA), toxin A and/or toxin B] in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LLH	Reagents, Clostridium Difficile Toxin

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0fc963b4-5202-4fd3-af19-0c92dfdd6d9d
Public Version Date: August 20, 2024
Public Version Number: 5
DI Record Publish Date: December 23, 2022