Duns Number:092815364
Device Description: ImmunoCard Toxins A & B is a rapid, qualitative, horizontal-flow enzyme immunoassay (EIA) 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.
Catalog Number
712050
Brand Name
ImmunoCard Toxins A & B
Version/Model Number
712050
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K041003
Product Code
LLH
Product Code Name
Reagents, Clostridium Difficile Toxin
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
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 149 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 46 |
| 3 | A medical device with high risk that requires premarket approval | 1 |