Duns Number:388240673
Device Description: For the quantitative measurement of immunoglobulin G in human serum, plasma and cerebrospi For the quantitative measurement of immunoglobulin G in human serum, plasma and cerebrospinal fluid (CSF) an urine on the Dimension Vista® System
Catalog Number
K7056
Brand Name
DImension Vista® Immunoglobulin G Flex® reagent cartridge
Version/Model Number
10445903
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
K081161,K081161
Product Code
CFN
Product Code Name
METHOD, NEPHELOMETRIC, IMMUNOGLOBULINS (G, A, M)
Public Device Record Key
a3f5fe94-d6ff-4f9f-a62f-459c64d40031
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 |