Duns Number:388240673
Device Description: For the quantitative measurement of immunoglobulin light chains, type kappa in human serum For the quantitative measurement of immunoglobulin light chains, type kappa in human serum and plasma on the Dimension Vista® System
Catalog Number
K7049
Brand Name
Dimension Vista® Flex® reagent cartridge KAPPA
Version/Model Number
10465671
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"
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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
K082503,K082503
Product Code
DEH
Product Code Name
LAMBDA, ANTIGEN, ANTISERUM, CONTROL
Public Device Record Key
1aede223-584f-4937-a4e7-7e54c8a97a07
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 |