Duns Number:388240673
Device Description: Solution for preparing dilutions for immunochemical determinations with the Dimension Vist Solution for preparing dilutions for immunochemical determinations with the Dimension Vista® System
Catalog Number
OUMT05
Brand Name
N Diluent
Version/Model Number
10469513
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K860894,K860894
Product Code
CFN
Product Code Name
METHOD, NEPHELOMETRIC, IMMUNOGLOBULINS (G, A, M)
Public Device Record Key
4414d821-3279-4770-af6e-3fb63cd6a156
Public Version Date
November 18, 2021
Public Version Number
5
DI Record Publish Date
September 24, 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 | 25 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 101 |