Duns Number:961027315
Device Description: H. pylori Stool Antigen ELISA Kit
Catalog Number
1077-25EIA
Brand Name
CARDINAL HEALTH
Version/Model Number
1077-25EIA
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 31, 2019
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K053335,K053335
Product Code
LYR
Product Code Name
Helicobacter pylori
Public Device Record Key
0d2dfb93-44a6-40f9-ab4c-8f0660c81702
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
February 01, 2019
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 | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |