FDA UDI
In Commercial Distribution
🇺🇸 United States
DC-UIBC-CAL
DI: 00628063401024
·
Model: SE-090
·
SEKISUI DIAGNOSTICS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
6
Basic Information
- Brand Name
- DC-UIBC-CAL
- Primary DI
- 00628063401024
- Version / Model
- SE-090
- Catalog Number
- SE-090
- Company Name
- SEKISUI DIAGNOSTICS, LLC
- Labeler DUNS
- 966812344
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 6
- Record Status
- Published
- Publish Date
- 2017-03-06
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 999aa16f-fdf4-4fc8-a3bc-aef661e1ae06
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
- No
- 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 |
|---|---|---|---|---|
| JIT | CALIBRATOR, SECONDARY | Clinical Chemistry | 862.1150 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58194 | Unsaturated iron binding capacity (UIBC) IVD, calibrator | A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of unsaturated iron binding capacity (UIBC) of a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00628063401024 | GS1 | ||||
| Unit of Use | 10628063401021 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K163078 | 000 |