Duns Number:092815364
Device Description: The ImmunoCard H. pylori enzyme immunoassay (EIA) is an in vitro qualitative procedure for The ImmunoCard H. pylori enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of IgG to Helicobacter pylori in human serum, plasma, or whole blood. Test results are intended to aid in the diagnosis of H. pylori infection. The ImmunoCard H. pylori assay may be performed in clinical laboratories and physician's offices.
Catalog Number
710030
Brand Name
ImmunoCard H. pylori
Version/Model Number
710030
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
K961508
Product Code
LYR
Product Code Name
Helicobacter Pylori
Public Device Record Key
176af6b8-b00b-4cab-9f86-bcbd4329b117
Public Version Date
August 19, 2020
Public Version Number
1
DI Record Publish Date
August 11, 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 |