Duns Number:296822794
Device Description: HBS HBsAg Kit 100 Test
Catalog Number
LKHB1(D)
Brand Name
IMMULITE®/IMMULITE®1000 Systems HBS HBsAg
Version/Model Number
10374038
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 31, 2018
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
P010050,P010050,P010050,P010050,P010050,P010050,P010050
Product Code
LOM
Product Code Name
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
Public Device Record Key
8428efbd-4e7e-48b4-88d8-43fa4a6a48c5
Public Version Date
November 18, 2021
Public Version Number
7
DI Record Publish Date
September 24, 2014
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 | 143 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 493 |
| 3 | A medical device with high risk that requires premarket approval | 22 |