Duns Number:315028860
Device Description: Anti-HBs CC 3 Elecsys
Catalog Number
04985354160
Brand Name
Anti-HBs CalCheck
Version/Model Number
04985354160
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
P010054
Product Code
LOM
Product Code Name
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
Public Device Record Key
a2d90031-0496-410e-b96a-137bc7b5d687
Public Version Date
November 10, 2021
Public Version Number
3
DI Record Publish Date
August 30, 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 | 289 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 760 |
| 3 | A medical device with high risk that requires premarket approval | 63 |
| U | Unclassified | 4 |