Duns Number:160990313
Device Description: HpOne detects the urease enzyme for the presumptive identification of Helicobacter pylori HpOne detects the urease enzyme for the presumptive identification of Helicobacter pylori in gastric mucosal biopsies. It is intended for in-vitro diagnostic use only.
Catalog Number
GIS-64
Brand Name
HpOne
Version/Model Number
GIS-64
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K012411,K012411,K012411
Product Code
LYR
Product Code Name
Helicobacter Pylori
Public Device Record Key
75a94dab-3953-4626-93d1-d39a66a22c9e
Public Version Date
July 16, 2021
Public Version Number
1
DI Record Publish Date
July 08, 2021
Package DI Number
20893029002506
Quantity per Package
20
Contains DI Package
00893029002502
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Dispenser
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 9 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |