Duns Number:630822989
Catalog Number
-
Brand Name
LIAISON XL MUREX HBcIgM
Version/Model Number
318140
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
-
Product Code Name
-
Public Device Record Key
e1d279e6-3dcf-4b35-a47f-b563b36d37b6
Public Version Date
April 21, 2021
Public Version Number
1
DI Record Publish Date
April 13, 2021
Package DI Number
18056771103388
Quantity per Package
10
Contains DI Package
08056771103381
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
3 | A medical device with high risk that requires premarket approval | 3 |