IVDR
All CE-IVD-marked RECIPE products comply with IVD-Directive 98/78/EC (IVDD).
The IVDD was repealed by Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) on 26.05.2022.
Transitional provisions have been implemented in the IVDR by Regulation (EU) 2022/112. As a result, risk class dependent grace periods were granted, which allow manufacturers to place IVDD-conform products on the market further on.
All RECIPE products are risk class B or C. The grace periods according to EU Regulation 2024/1860 for these products will end on 31.12.2029 for risk class B and on 31.12.2028 for risk class C. All RECIPE products are valid under IVDD until the end of the grace periods.
RECIPE devices are IVDR compliant according to Regulation (EU) 2017/746 on in vitro diagnostic medical devices, Annex IX, Chapters I and III (BSI EU IVDR certificate no. 759872).
RECIPE IVDR compliant devices (as of 18/05/2026):
| Order no. | Device name |
|---|---|
| 1000 | ClinRep® Complete Kit for Catecholamines Plasma |
| 2000 | ClinRep® Complete Kit for Catecholamines Urine |
| 3500 | ClinRep® Complete Kit for VMA, HVA, 5-HIAA in Urine, advanced |
| 4500 | ClinRep® Complete Kit for Metanephrines in Urine, advanced |
| 14000 | ClinRep® Complete Kit, advanced, for Antiepileptics in Serum and Plasma |
| 14100 | ClinRep® Complete Kit for Antiepileptics in Serum and Plasma by UHPLC |
| 17200 | ClinEasy® Complete Kit for 5-Aminolevulinic Acid and Porphobilinogen in Urine |
| 17300 | ClinEasy® Complete Kit for Porphobilinogen in Urine |
| 21000 | ClinRep® Complete Kit for CDT (Carbohydrate-deficient Transferrin) in Serum |
| 21100 | ClinRep® Complete Kit for CDT (Carbohydrate-deficient Transferrin) in Serum, on-line analysis |
| 21200 | ClinRep® Complete Kit for CDT (Carbohydrate-deficient Transferrin) in Serum, on-line analysis, automated |
| 22000 | ClinRep® Complete Kit for Vitamin A and E in Serum and Plasma |
| 22100 | ClinRep® Complete Kit for Vitamin A and E in Serum and Plasma by UHPLC |
| 23000 | ClinRep® Complete Kit for Homocysteine in Plasma |
| 24000 | ClinRep® Complete Kit for Vitamin B1 in Whole Blood |
| 25000 | ClinRep® Complete Kit for Vitamin B2 in Whole Blood |
| 26000 | ClinRep® Complete Kit for Vitamin B6 in Whole Blood and Plasma |
| 27000 | ClinRep® Chromatography Kit for Vitamins B1, B2 in Whole Blood and Vitamin B6 in Plasma and Whole Blood |
| 27001 | ClinRep® Sample Preparation Kit for Vitamin B1 in Whole Blood |
| 27002 | ClinRep® Sample Preparation Kit for Vitamin B2 in Whole Blood |
| 27006 | ClinRep® Sample Preparation Kit for Vitamin B6 in Plasma and Whole Blood |
| 35000 | ClinRep® Complete Kit for 25-OH-Vitamin D2/D3 in Plasma and Serum |
| 35100 | ClinRep® Complete Kit for 25-OH-Vitamin D2/D3 in Plasma and Serum by UHPLC |
| MS1100 | ClinMass® Complete Kit, advanced, for Immunosuppressants in Whole Blood, on-line analysis |
| MS1200 | ClinMass® Complete Kit, advanced, for Immunosuppressants in Whole Blood, automated on-line analysis with LHS (well plates) |
| MS1300 | ClinMass® Complete Kit, advanced, for Immunosuppressants in Whole Blood, automated on-line analysis with LHS (well plates and filter plates) |
| MS2000 | ClinMass® Complete Kit for Homocysteine in Plasma and Serum |
| MS2100 | ClinSpot® Complete Kit for Homocysteine in Dried Blood Spots (DBS) |
| MS5100 | ClinMass® Complete Kit, advanced, for Methylmalonic Acid in Serum, Plasma and Urine |
| MS7000 | ClinMass® Complete Kit for 25-OH-Vitamin D2/D3 in Plasma and Serum, on-line analysis |
| MS7100 | ClinMass® Complete Kit for 25-OH-Vitamin D2/D3 in Plasma and Serum, automated on-line analysis with LHS (well plates) |
| MS7200 | ClinMass® Complete Kit for 25-OH-Vitamin D2/D3 in Plasma and Serum, automated on-line analysis with LHS (well plates and filter plates) |
| MS8000 | ClinMass® Complete Kit for Ethylglucuronide and Ethylsulfate in Urine |
| MS8100 | ClinMass® Supplement Kit for Ethylglucuronide and Ethylsulfate in Plasma and Serum |
| MS9100 | ClinMass® Add-on Set for Tricyclic Antidepressants in Serum and Plasma |
| MS9200 | ClinMass® Add-on Set for Antiepileptic Drugs in Serum and Plasma |
| MS9300 | ClinMass® Add-on Set for Neuroleptics in Serum and Plasma |
| MS9400 | ClinMass® Add-on Set for Antidepressants in Serum and Plasma |
| MS9500 | ClinMass® Add-On Set for Benzodiazepines in Serum and Plasma |
| MS9600 | ClinMass® Add-on Set for Antimycotics in Serum and Plasma |
| MS9700 | ClinMass® Add-on Set for Antibiotics in Serum and Plasma |
| MS10000 | ClinSpot® Complete Kit for Amino Acids and Acylcarnitines in Dried Blood Spots (DBS) |
| MS10100 | ClinSpot® Complete Kit for Amino Acids and Acylcarnitines in Dried Blood Spots (DBS) with Filter-Plates |
| MS10200 | ClinSpot® Complete Kit for Amino Acids and Acylcarnitines in Dried Blood Spots (DBS), non-derivatised |
| MS10300 | ClinSpot® Complete Kit for Amino Acids and Acylcarnitines in Dried Blood Spots (DBS) with Filter-Plates, non-derivatised |
| MS11000 | ClinMass® Complete Kit for Free Metanephrines in Plasma, on-line analysis |
| MS11100 | ClinMass® Complete Kit for Free Metanephrines in Plasma |
| MS13000 | ClinMass® Complete Kit for Vitamins B1, B2 in Whole Blood and Vitamin B6 in Plasma and Whole Blood |
| MS99100 | ClinMass® Add-on Set for Mycophenolic Acid in Serum and Plasma |
| MS99200 | ClinMass® Add-on Set for Immunosuppressants in Whole Blood |
| MS100000 | ClinDART® Complete Kit for Mycophenolic Acid in Serum and Plasma |