Duns Number:354553091
Device Description: Mercodia Diabetes Antigen Control is designed to be used as a two-level control for human Mercodia Diabetes Antigen Control is designed to be used as a two-level control for human insulin, C-peptide and proinsulin. It is manufactured from human serum and human insulin, C-peptide and proinsulin.
Catalog Number
10-1134-01
Brand Name
Diabetes Antigen Control (Unassayed)
Version/Model Number
10-1134-01
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
OHQ
Product Code Name
Multi-Analyte Controls Unassayed
Public Device Record Key
fc872c3b-547a-407e-a47b-309be21ec9d3
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 |