Duns Number:961027315
Device Description: H.pylori Rapid Test
Catalog Number
B1077-25
Brand Name
CARDINAL HEALTH
Version/Model Number
B1077-25
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 01, 2021
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
-
Product Code
LYR
Product Code Name
Helicobacter pylori
Public Device Record Key
22a42c46-4d14-45e7-b384-d420cc8609bd
Public Version Date
September 01, 2021
Public Version Number
6
DI Record Publish Date
September 01, 2016
Package DI Number
50885380020283
Quantity per Package
40
Contains DI Package
20885380020282
Package Discontinue Date
August 31, 2021
Package Status
Not in Commercial Distribution
Package Type
CASE
| 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 |