Duns Number:092815364
Device Description: Premier H. pylori is an enzyme immunoassay (EIA) for the in vitro qualitative detection of Premier H. pylori is an enzyme immunoassay (EIA) for the in vitro qualitative detection of IgG antibodies to Helicobacter pylori in human serum and plasma. Test results are intended to aid in the diagnosis of H. pylori infection.
Catalog Number
606096
Brand Name
PREMIER H. pylori
Version/Model Number
606096
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
K945558
Product Code
LYR
Product Code Name
Helicobacter Pylori
Public Device Record Key
89276520-3a46-4b31-809e-4f8859f040e8
Public Version Date
September 09, 2020
Public Version Number
1
DI Record Publish Date
September 01, 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 |