RX monaco

Primary DI
05055273207750
Brand
RX monaco
Company
RANDOX LABORATORIES LIMITED
Model
RX5000
Catalog number
RX5000
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.
Published
2023-09-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055273207750PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055273207750050552732077505055273207750

GMDN Terms#

Term, Definition table
TermDefinition
Multiple clinical chemistry analyser IVD, laboratoryAn 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius32 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+442894451070technical.services@randox.com

Regulatory Flags#

DUNS number
227530649
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

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