Duns Number:606034197
Device Description: LIFECODES Class I ID is a bead-based immunoassay used to qualitatively detect Panel Reacti LIFECODES Class I ID is a bead-based immunoassay used to qualitatively detect Panel Reactive HLA IgG antibodies (PRA)
Catalog Number
628200
Brand Name
LIFECODES Class I ID Typing Kit for use with Luminex
Version/Model Number
628200
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
BK040035
Product Code
MZI
Product Code Name
Test,Qualitative,For Hla,Non-Diagnostic
Public Device Record Key
d8d30011-dc85-49d5-a72e-ed6ae48326c8
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 15, 2016
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 |