AccessGUDID - DEVICE: Randox Evidence™ (05055273214024)

GUDID

Device Identifier (DI) Information

Brand Name: Randox Evidence™
Version or Model: EV3600
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EV3600
Company Name: RANDOX LABORATORIES LIMITED

Primary DI Number: 05055273214024
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 227530649 *Terms of Use

Device Description: The RANDOX evidence® system is a fully automated, continuous access immunoanalyser using protein biochip array technology. It is intended for the in-vitro qualitative, semi-quantitative or fully quantitative determination of various diagnostic markers.

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?
56726	Multiplex analyser IVD, laboratory, automated	A mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative simultaneous determination of multiple chemical and/or biological markers in a single clinical specimen using an immunological method which incorporates multiple antibodies arranged on a solid surface (e.g., slide, plate, membrane) or coated to micro-particles. It typically includes a system for the detection of bound target antigen (e.g., chemiluminescent, fluorescent, photometric, magnetic detector), together with sample processing, data processing and data display software. It operates with minimal technician involvement and complete automation of all procedural steps.	Obsolete	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 [?]
K030360	000

Device Exempt from Premarket Submission: No 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: 233f208b-2689-465c-aa4e-c5162c93f441
Public Version Date: December 21, 2020
Public Version Number: 2
DI Record Publish Date: June 07, 2018