Duns Number:064608573
Device Description: HBsAgII (HBsII) QC Kit - Atellica IM - CLT 2 x 2 x 15.0mL
Catalog Number
10995605
Brand Name
Atellica™ IM HBsII QC
Version/Model Number
10995605
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)
-
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
cf06c9a3-debc-42d4-8a52-97dfda1212cd
Public Version Date
February 16, 2022
Public Version Number
5
DI Record Publish Date
October 16, 2018
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 | 363 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 829 |
| 3 | A medical device with high risk that requires premarket approval | 57 |
| U | Unclassified | 7 |