Duns Number:965476641
Device Description: The Luminex® FLEXMAP 3D® Performance Verification Kit is used to run performance verificat The Luminex® FLEXMAP 3D® Performance Verification Kit is used to run performance verification on the FLEXMAP 3D analyzer. The Luminex FLEXMAP 3D® Performance Verification Kit includes sufficient reagents to perform 25 verifications of the calibration and optical integrity for the Luminex FLEXMAP 3D® System.
Catalog Number
-
Brand Name
FLEXMAP 3D® Performance Verification Kit
Version/Model Number
F3DIVD-PVER-K25
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
K121399,K133302
Product Code
NSU
Product Code Name
Instrumentation for clinical multiplex test systems
Public Device Record Key
85fa610b-c5ec-4b2d-b042-9dd46d662a30
Public Version Date
September 16, 2022
Public Version Number
4
DI Record Publish Date
September 09, 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 | 47 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 52 |