AccessGUDID - DEVICE: RX monaco (05055273207750)

GUDID

Device Identifier (DI) Information

Brand Name: RX monaco
Version or Model: RX5000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RX5000
Company Name: RANDOX LABORATORIES LIMITED

Primary DI Number: 05055273207750
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 227530649 *Terms of Use

Device Description: The RX monaco Analyser is a fully automated clinical chemistry analyser that has been designed and developed to be operated in a wide range of laboratory settings within different industries. These include clinical, hospital, academic, research and development, veterinary, food and wine laboratories. The RX monaco can detect a wide range of analytes in various liquid matrices. These include serum, plasma, urine, CSF and supernatants. The RX monaco is designed to be used by qualified laboratory staff, in conjunction with current Randox clinical chemistry reagents, to generate a result. The results that are generated are intended to be interpreted by a trained professional to aid in the diagnosis or interpretation of its application. The RX monaco is supplied with dedicated software that has been designed to assist and guide the operator through the operational processes. The software allows the RX monaco to interface with a host system or computer to assist in the processing, storing, ordering and managing of tests and test results.

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?
56676	Multiple clinical chemistry analyser IVD, laboratory	An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro detection of multiple clinical chemistry analytes in a clinical specimen, using one or more technologies (e.g., microfluidics, electrometry, spectrophotometry, colorimetry, fluorimetry, radiometry, chemiluminescence). Analytes detected may include electrolytes, specific proteins, clinical chemistry substrates (e.g., lipid profile), liver and/or cardiac function test analytes, and/or enzymes.	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
Storage Environment Temperature: between 15 and 32 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a96730b0-cfa4-4317-839b-60965a9b99e2
Public Version Date: September 20, 2023
Public Version Number: 1
DI Record Publish Date: September 12, 2023