Duns Number:312576506
Device Description: Human lymphocytes for 12 detections of human HLA-DR/DQ antibodies in the complement-depend Human lymphocytes for 12 detections of human HLA-DR/DQ antibodies in the complement-dependent microlymphocytotoxicity test
Catalog Number
-
Brand Name
Lymphoscreen DR 30x2
Version/Model Number
823350
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
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
BK980044
Product Code
MZI
Product Code Name
Test,Qualitative,For Hla,Non-Diagnostic
Public Device Record Key
0b411353-c4cb-4a41-b83b-11cd141a3999
Public Version Date
July 06, 2018
Public Version Number
2
DI Record Publish Date
March 08, 2018
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 |