Duns Number:784143778
Device Description: The ALPCO Insulin Chemiluminescence ELISA is designed for the quantitative determination o The ALPCO Insulin Chemiluminescence ELISA is designed for the quantitative determination of insulin in human serum, heparin plasma, and tissue culture supernatants. For in vitro diagnostic use.
Catalog Number
80-INSHU-CH01
Brand Name
STELLUX® Chemi Human Insulin ELISA
Version/Model Number
80-INSHU-CH01
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
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
0e8a6aab-e1db-4320-983f-535997492fb5
Public Version Date
July 27, 2020
Public Version Number
1
DI Record Publish Date
July 17, 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 | 42 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |