Duns Number:354553091
Device Description: Mercodia Ultrasensitive C-peptide ELISA provides a method for the quantitative determinati Mercodia Ultrasensitive C-peptide ELISA provides a method for the quantitative determinationof human C-peptide in serum, plasma or urine.
Catalog Number
10-1141-01
Brand Name
Mercodia Ultrasensitive C-peptide ELISA
Version/Model Number
10-1141-01
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
JKD
Product Code Name
Radioimmunoassay, C-Peptides Of Proinsulin
Public Device Record Key
66698b15-0b0a-4518-8b1e-7df5dba5c2fd
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 |