AccessGUDID - DEVICE: chemagic 360-D (06438147356706)

GUDID

Device Identifier (DI) Information

Brand Name: chemagic 360-D
Version or Model: 2024-0010
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2024-0010
Company Name: Wallac Oy

Primary DI Number: 06438147356706
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 540156544 *Terms of Use

Device Description: The chemagic 360-D is an automated laboratory instrument used in preanalytical preparation of samples through magnetic particle separation technology for use with in vitro diagnostic clinical sample concentrating kits. The instrument is intended for use by healthcare professionals such as laboratory personnel or physicians who are trained in molecular biology techniques.

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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60528	Magnetic particle separation instrument IVD	An electrically-powered automated or semi-automated laboratory instrument intended to be used for the automated pre-analytical extraction of specific molecules from a clinical specimen using magnetic particle separation techniques. It is a software-controlled, liquid handling robotic instrument that processes solutions using sequential immersion of magnetized rods, to attract labelled molecules, and rotation of demagnetized rods to create a new suspension/solution, and is typically used for nucleic acid isolation procedures.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJH	Clinical Sample Concentrator

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: f042b6f9-5593-4a16-927c-12ffa39f0fce
Public Version Date: September 16, 2022
Public Version Number: 2
DI Record Publish Date: February 25, 2019