Duns Number:354553091
Device Description: Mercodia Insulin ELISA provides a method for the quantitative determination of human insul Mercodia Insulin ELISA provides a method for the quantitative determination of human insulinin serum or plasma.
Catalog Number
10-1113-01
Brand Name
Mercodia Insulin ELISA
Version/Model Number
10-1113-01
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
380ab346-acee-4290-8a87-84095d1eaf80
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 |