FDA UDI
In Commercial Distribution
🇺🇸 United States
Diabetes Antigen Control (Unassayed)
DI: 07350108630078
·
Model: 10-1134-01
·
Mercodia AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Diabetes Antigen Control (Unassayed)
- Primary DI
- 07350108630078
- Version / Model
- 10-1134-01
- Catalog Number
- 10-1134-01
- Company Name
- Mercodia AB
- Labeler DUNS
- 354553091
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-04-08
- Public Version
- 2
- Public Version Date
- 2023-10-06
- Public Version Status
- Update
- Public Device Record Key
- fc872c3b-547a-407e-a47b-309be21ec9d3
Device Description
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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OHQ | Multi-Analyte Controls Unassayed | Clinical Chemistry | 862.1660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65050 | Multiple insulin synthesis pathway analyte IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of multiple analytes of the insulin synthesis pathway (i.e., proinsulin, insulin, and C-peptide) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07350108630078 | GS1 |
Customer Contacts
- Phone
- +4618570070
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius