FDA UDI
In Commercial Distribution
🇺🇸 United States
Migele Gel Electrophoresis Unit
DI: 06438147368907
·
Model: 2118-0010
·
Wallac Oy
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Migele Gel Electrophoresis Unit
- Primary DI
- 06438147368907
- Version / Model
- 2118-0010
- Catalog Number
- 2118-0010
- Company Name
- Wallac Oy
- Labeler DUNS
- 540156544
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-11-28
- Public Version
- 3
- Public Version Date
- 2022-09-16
- Public Version Status
- Update
- Public Device Record Key
- 0b42a432-a889-4ff1-9b4a-630a762d455c
Device Description
Migele™ Gel Electrophoresis Unit (GEU) is intended for professional use together with power supply, water bath and isoelectric focusing (IEF) gels. GEU is used for the isoelectric point-based separation of sample compounds, e.g. hemoglobin variants found in blood samples, by applying a given amount of electrical current to the immobilized pH-gradient containing agarose.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JJN | Apparatus, Electrophoresis, For Clinical Use | Clinical Chemistry | 862.2485 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57837 | Electrophoresis analyser IVD | An electrically-powered automated or semi-automated laboratory instrument or system intended to be used for the qualitative and/or quantitative in vitro determination of various molecules (e.g., DNA, RNA, proteins) in a clinical specimen based on their size, ionic charge and/or rate of migration through an electrically charged field. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06438147368907 | GS1 |