Duns Number:312576506
Device Description: Human lymphocytes for 6 detections of human HLA-ABC antibodies in the complement-dependent Human lymphocytes for 6 detections of human HLA-ABC antibodies in the complement-dependent microlymphocytotoxicity test
Catalog Number
823300
Brand Name
Lymphoscreen ABC-60
Version/Model Number
823300
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 08, 2018
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
BK980033
Product Code
MZI
Product Code Name
Test,Qualitative,For Hla,Non-Diagnostic
Public Device Record Key
8399256a-671a-4b2a-b481-fbcb4476b9ce
Public Version Date
July 06, 2018
Public Version Number
3
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 |