RX monaco
Basic Information
- Brand Name
- RX monaco
- Primary DI
- 05055273207750
- Version / Model
- RX5000
- Catalog Number
- RX5000
- Company Name
- RANDOX LABORATORIES LIMITED
- Labeler DUNS
- 227530649
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-09-12
- Public Version
- 1
- Public Version Date
- 2023-09-20
- Public Version Status
- New
- Public Device Record Key
- a96730b0-cfa4-4317-839b-60965a9b99e2
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
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | Clinical Chemistry | 862.2160 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05055273207750 | GS1 |
Customer Contacts
- Phone
- +442894451070
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 32 Degrees Celsius