Duns Number:540156544
Device Description: Migele™ Gel Electrophoresis Unit (GEU) is intended for professional use together with powe 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.
Catalog Number
2118-0010
Brand Name
Migele Gel Electrophoresis Unit
Version/Model Number
2118-0010
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
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JJN
Product Code Name
Apparatus, Electrophoresis, For Clinical Use
Public Device Record Key
0b42a432-a889-4ff1-9b4a-630a762d455c
Public Version Date
September 16, 2022
Public Version Number
3
DI Record Publish Date
November 28, 2018
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 | 57 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 38 |
| 3 | A medical device with high risk that requires premarket approval | 2 |