Duns Number:315028860
Device Description: HBsAg Confirmatory Test Elecsys cobas e V2
Catalog Number
09127127190
Brand Name
Elecsys HBsAg Confirmatory Test
Version/Model Number
09127127190
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
P160019
Product Code
LOM
Product Code Name
Test, hepatitis b (b core, be antigen, be antibody, b core igm)
Public Device Record Key
b3c32945-669c-4fa3-b42a-9fd1253f6f5a
Public Version Date
February 03, 2022
Public Version Number
1
DI Record Publish Date
January 26, 2022
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 |