Duns Number:606034197
Device Description: LIFECODES LSA Class II is a bead-based Immunoassay used to qualitatively detect HLA IgG an LIFECODES LSA Class II is a bead-based Immunoassay used to qualitatively detect HLA IgG antibodies to aid donor and recipient matching in transfusion or transplantation.
Catalog Number
265200IVD
Brand Name
LIFECODES LSA Class II
Version/Model Number
265200IVD
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
BK210574
Product Code
MZI
Product Code Name
Test, Qualitative, For Hla, Non-Diagnostic
Public Device Record Key
8b9b3d9d-6c17-4146-bc47-03bda328e7ae
Public Version Date
April 14, 2022
Public Version Number
1
DI Record Publish Date
April 06, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 54 |
| U | Unclassified | 36 |