Duns Number:388240673
Device Description: For the quantitative measurement of immunoglobulin E in human serum and plasma (heparin or For the quantitative measurement of immunoglobulin E in human serum and plasma (heparin or EDTA) on the Dimension Vista® System
Catalog Number
K7054
Brand Name
DImension Vista® Immunoglobulin E Flex® reagent cartridge
Version/Model Number
10445902
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
K063425,K063425
Product Code
DGC
Product Code Name
IGE, ANTIGEN, ANTISERUM, CONTROL
Public Device Record Key
8f64b2d0-017c-4ed7-93a0-9af4964283e8
Public Version Date
June 10, 2022
Public Version Number
6
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 |