AccessGUDID - DEVICE: IDS-iSYS Cartridge Check System (CCS) (05425030426012)

GUDID

Device Identifier (DI) Information

Brand Name: IDS-iSYS Cartridge Check System (CCS)
Version or Model: IS-6010
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Immunodiagnostic Systems SA

Primary DI Number: 05425030426012
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 372668418 *Terms of Use

Device Description: No description.

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:	Yes
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?
65954	Immunoassay instrument/analyser general performance control kit IVD	A collection of reagents of known reactivity (negative or positive) intended to be used to verify the overall performance of an immunoassay instrument/analyser [e.g., enzyme immunoassay (EIA) analyser]. It is not specific to an analyte.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJE	Analyzer, Chemistry (Photometric, Discrete), 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
Special Storage Condition, Specify: Store the cartridges in a vertical position. Do not freeze the cartridges
Storage Environment Temperature: between 2 and 8 Degrees Celsius
Handling Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 876d2fe1-f28b-48f9-b88b-708dc9640b17
Public Version Date: July 16, 2024
Public Version Number: 6
DI Record Publish Date: April 01, 2016