FDA UDI
In Commercial Distribution
🇺🇸 United States
MINICAP CDT
DI: 03607360022085
·
Model: 2208
·
SEBIA
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MINICAP CDT
- Primary DI
- 03607360022085
- Version / Model
- 2208
- Catalog Number
- 2208
- Company Name
- SEBIA
- Labeler DUNS
- 276801933
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-08
- Public Version
- 2
- Public Version Date
- 2023-09-13
- Public Version Status
- Update
- Public Device Record Key
- 867a9a51-f384-4f6f-8a29-17f54ec6e648
Device Description
CARBOHYDRATE DEF TRANSFERRIN BY MINICAP CE
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65813 | Transferrin/transferrin isoform IVD, kit, electrophoresis | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of transferrin or a transferrin isoform(s) [e.g., beta-2-transferrin, carbohydrate deficient transferrin] in a clinical specimen, using an electrophoresis method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03607360022085 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- FRAGILE HANDLE WITH CARE KEEP DRY THIS WAY UP