Duns Number:965476641
Device Description: Sheath Fluid PLUS is the delivery medium of the sample to the optics component.
Catalog Number
-
Brand Name
xMAP® Sheath Fluid PLUS
Version/Model Number
40-50035
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,K121399
Product Code
NSU
Product Code Name
Instrumentation for clinical multiplex test systems
Public Device Record Key
0eb0eb94-65e3-4ca6-b2da-88048f4929d5
Public Version Date
September 16, 2022
Public Version Number
2
DI Record Publish Date
November 04, 2020
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 |