ClinMass®
Basic Information
- Primary DI
- D-MS50000Q4
- Basic UDI-DI Code
- B-MS50000Q4
- Reference
- MS50000
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- RECIPE Chemicals + Instruments GmbH
Additional Description
The ClinMass® Complete Kit (order no. MS50000) is intended for the quantitative determination of trace elements in human plasma and serum by single and triple quadrupole inductively coupled plasma mass spectrometry (ICP-MS, ICP-MS/MS). The list of measurable traceability is shown in section 4.3.2 in this instruction of use (IFU). The analytical results of the devices are intended to be used for the evaluation of a (patho-) physiological condition in accordance with published reference ranges. The device is not intended for screening, diagnosis, prognosis. Quantitative test results may require additional analytical and diagnostic activities at the discretion of the treating clinician/medical doctor. The intended target population is a general population of subjects. There are no restrictions regarding age, gender or ethnicity. The ClinMass® Complete Kit is intended for application on qualified ICP-MS and ICP-MS/MS systems by professional clinical laboratories in accordance with this user manual. The kit is not designed for combination with components from other manufacturers. The analytical method is not intended for automation.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W01010499 | MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).