Duns Number:985307301
Device Description: Alinity i HBsAg Qualitative II Reagent Kit 200 Tests
Catalog Number
08P1021
Brand Name
Alinity
Version/Model Number
08P1021
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
-
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
-
Product Code
LOM
Product Code Name
Test, hepatitis b (b core, be antigen, be antibody, b core igm)
Public Device Record Key
a028cb7b-c1fb-4633-ad8a-295cb649aa47
Public Version Date
November 24, 2021
Public Version Number
3
DI Record Publish Date
July 10, 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 | 21 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 26 |
| 3 | A medical device with high risk that requires premarket approval | 47 |