ClinSpot®
Basic Information
- Primary DI
- D-MS10000NQ
- Basic UDI-DI Code
- B-MS10000NQ
- Reference
- MS10000
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List B
- Status
- On The Market
- Manufacturer
- RECIPE Chemicals + Instruments GmbH
Additional Description
The ClinSpot® Complete Kits for Amino Acids and Acylcarnitines in Dried Blood Spots (DBS) with order nos. MS10000, MS10100, MS10200 and MS10300 are intended for newborn screening of phenylketonuria (PKU) by semi-quantitative analysis of phenylalanine and tyrosine in dried spots (DBS). In addition, the device is intended for the semi-quantitative determination of additional amino acids and acylcarnitines to evaluate a (patho-)physiological state that may be associated with inborn errors of metabolism. These results are not intended for screening, prognosis or for diagnosis. The list of measurable analytes is shown in the instruction manuals (IFU). Semi-quantitative results may require additional analytical and diagnostic activities at the discretion of the treating physician. The testing population are newborn babies without any restrictions regarding gender or ethnicity. The components of the devices have to be used in accordance with the corresponding instruction manual (IFU), a combination with components from other manufacturers is not intended. Devices are intended for application on qualified LC-MS/MS systems by professional clinical laboratories. The analytical methods are not intended for automation.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W01010402 | MULTIPLE SUBSTRATES ONLY - CLIN. CHEM LAB R. |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | CE635228 | BSI Group The Netherlands B.V. | Expired |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Annex 2 List B) and regulation (EU IVDD).