Duns Number:965476641
Device Description: Sheath fluid is the delivery medium of the sample to the optics component.
Catalog Number
-
Brand Name
xMAP® Sheath Fluid
Version/Model Number
40-50000
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
K073506,K083846,K140377
Product Code
NSU
Product Code Name
Instrumentation for clinical multiplex test systems
Public Device Record Key
b5b1bd84-e847-41a3-b9f0-bc4640a745b4
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 |