Duns Number:197934250
Device Description: For the quantitative determination of human insulin in serum and plasma by immunoturbidime For the quantitative determination of human insulin in serum and plasma by immunoturbidimetric assay.
Catalog Number
KAI-040
Brand Name
K-ASSAY® Insulin Reagent
Version/Model Number
KAI-040
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 16, 2022
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)
Yes
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
eb233724-cea2-48b9-8450-952d2549af4b
Public Version Date
August 17, 2022
Public Version Number
3
DI Record Publish Date
September 16, 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 | 49 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 66 |