Duns Number:354553091
Device Description: Insulin ELISA Kit provides a method for the quantitative determination of human insulin in Insulin ELISA Kit provides a method for the quantitative determination of human insulin inserum or plasma.As with all diagnostic tests, a definitve clinical diagnosis should not be based on the results of asingle test, but should be made by the physician after all clinical findings have been evaluated.The analysis should be performed by trained laboratory professionals.
Catalog Number
K2379
Brand Name
Insulin ELISA Kit (DAKO)
Version/Model Number
K2379
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CFP
Product Code Name
Radioimmunoassay, Immunoreactive Insulin
Public Device Record Key
489c44c9-8951-45fb-88e9-07aa1017cd1d
Public Version Date
April 16, 2020
Public Version Number
1
DI Record Publish Date
April 08, 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 | 13 |