Duns Number:312576506
Device Description: for 6 detections of human HLA-DR/DQ antigens in the complement-dependent microlymphocytoto for 6 detections of human HLA-DR/DQ antigens in the complement-dependent microlymphocytotoxicity test
Catalog Number
823102
Brand Name
Lymphotype HLA-DR/DQ 72
Version/Model Number
823102
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 16, 2017
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
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
GKZ
Product Code Name
Counter, Differential Cell
Public Device Record Key
68ed9fc3-21aa-42fc-8eb5-d42df31c5fff
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
July 01, 2015
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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 38 |
| U | Unclassified | 21 |