AccessGUDID - DEVICE: ImmunoCard Toxins A & B (00840733101786)

GUDID

Device Identifier (DI) Information

Brand Name: ImmunoCard Toxins A & B
Version or Model: 712050
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 712050
Company Name: MERIDIAN BIOSCIENCE, INC.

Primary DI Number: 00840733101786
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 092815364 *Terms of Use

Device Description: ImmunoCard Toxins A & B is a rapid, qualitative, horizontal-flow enzyme immunoassay (EIA) for detecting Clostridium difficile Toxins A and B in human stool. This assay is used as an aid in the diagnosis of C. difficile-associated disease. In the US, ImmunoCard Toxins A & B is not intended for point-of-care use. The device is intended for moderately complex laboratories. In Canada, this device is not intended for point-of-care use.

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:	Yes
Prescription Use (Rx):	Yes
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 [?]
K041003	000

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
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: a9b7567b-7574-4272-a0b3-36e10502a2e7
Public Version Date: September 29, 2020
Public Version Number: 1
DI Record Publish Date: September 21, 2020