AccessGUDID - DEVICE: Migele Gel Electrophoresis Unit (06438147368907)

GUDID

Device Identifier (DI) Information

Brand Name: Migele Gel Electrophoresis Unit
Version or Model: 2118-0010
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2118-0010
Company Name: Wallac Oy

Primary DI Number: 06438147368907
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 540156544 *Terms of Use

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

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJN	Apparatus, Electrophoresis, For Clinical Use

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

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