Duns Number:118289289
Device Description: A sensitive flow analyzer capable of processing up to 100 bead regions simultaneously and A sensitive flow analyzer capable of processing up to 100 bead regions simultaneously and when used with One Lambda’s LABType and LABScreen family of products, the system allows the user to make assignments of HLA antibodies as well as HLA typing with the analysis support of HLA Fusion.
Catalog Number
LABSCNXS2
Brand Name
LABScan™ 100 Systems
Version/Model Number
N/A
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
-
Product Code
NSU
Product Code Name
Instrumentation For Clinical Multiplex Test Systems
Public Device Record Key
ec196a1d-3493-406e-bee5-f1755abd49a3
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 31, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 17 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |
| U | Unclassified | 370 |