Declarations of Conformity

Chromsystems attests the conformity for all of its in vitro diagnostic devices approved in Europe with applicable regulations and directives. The declarations of conformity are issued either according to IVD Directive 98/79/EC or according to IVDR Regulation 2017/746.

Please note that not all products listed here are available in the US.

1000/B – VMA, HVA, 5-HIAA in Urine - HPLC
15330 – Hemoglobin Variants - HPLC
15440 – β-Thalassemia Testing - HPLC
2020 – Metanephrines in Urine - HPLC
2020/COMBI – Metanephrines in Urine/Combined analysis - HPLC
21000 – Rufinamide, Felbamate and Lacosamide in Serum/Plasma - HPLC
22000-F and 22000/HR – Antiepileptic Drugs in Serum/Plasma, Fast Elution / High Resolution - HPLC
23000-F and 23000/HR – Antiepileptic Drugs in Serum/Plasma - automated HPLC
24000 – Levetiracetam (Keppra®) in Serum/Plasma - HPLC
25000 – Amiodarone and Desethylamiodarone in Serum/Plasma - HPLC
26000 – Olanzapine and Desmethylolanzapine in Serum/Plasma - HPLC
27037 – Itraconazole, Posaconazole and Voriconazole in Serum/Plasma - HPLC
3030 – Serotonin in Serum/Plasma/Whole Blood - HPLC
31000 – Vitamin B6 in Serum/Plasma or Whole Blood - HPLC
32000 – β-Carotene in Serum/Plasma - HPLC
34000, 34000/Premix, 34700/F, 34900/F, 34900/UHPLC – Vitamins A and E in Serum/Plasma - HPLC / UHPLC
35000 – Vitamin B1 in Whole Blood - HPLC
37000 – Vitamin B2 in Whole Blood - HPLC
38038 – 25-OH-Vitamin D3/D2 in Serum/Plasma - HPLC
38900/1000 – 25-OH-Vitamin D3/D2 in Serum/Plasma (Online Method) - HPLC
4000 – Serotonin in Urine - HPLC
41000 – o-Cresol, p-Cresol and Phenol in Urine - HPLC
43000 – Hippuric Acid, Methylhippuric Acids, Mandelic Acid and Phenylglyoxylic Acid in Urine - HPLC
44000 – Porphyrins in Urine - HPLC
45000 – Homocysteine in Serum/Plasma - HPLC
46000 – Mycophenolic Acid in Plasma/Serum - HPLC
47000 – trans,trans-Muconic Acid in Urine - HPLC
48000 – Crosslinks in Urine - HPLC
49000 – Benzodiazepines and Tricyclic Antidepressants in Serum/Plasma - HPLC
5000 – Catecholamines in Plasma - HPLC
51000 – 5-HIAA in Urine - HPLC
52052, 52052/Premix – Vitamin B1 in Whole Blood and Vitamin B6 in Whole Blood/Plasma - HPLC
52752/F – Vitamin B1/B6 in Whole Blood, fully automated analysis - HPLC
52952/UHPLC, 52952/UHPLC/F – High Throughput UHPLC, combined Vitamin B1/B6 Analysis - UHPLC
53000 – 1-Hydroxypyrene in Urine - HPLC
54020 54030 54330 54730 54930 – CDT in Serum - HPLC
55000 – MassChrom® Amino Acids and Acylcarnitines from Dried Blood - LC-MS/MS
57000 – MassChrom® Amino Acids and Acylcarnitines from Dried Blood / Non Derivatised - LC-MS/MS
6000 – Catecholamines in Urine - HPLC
6000/COMBI – Catecholamines in Urine, Combined analysis - HPLC
61000 – Antibiotics in Serum/Plasma - HPLC
62000, 62062 – MassChrom® 25-OH-Vitamin D3/D2 (and 3-epi-25-OH-Vitamin D3) in Serum/Plasma - LC-MS/MS
64000 – MassChrom® Methylmalonic Acid in Serum/Plasma and Urine - LC-MS/MS
65065 – Vitamin C in Plasma/Serum - HPLC
66000 – Glutathione in Whole Blood - HPLC
67000 – Malondialdehyde in Serum/Plasma - HPLC
68000 – Coenzyme Q10 in Serum/Plasma/Whole Blood - HPLC
69000 – MassChrom® Ethyl Glucuronide (EtG) and Ethyl Sulfate (EtS) in Urine – LC-MS/MS
72072 – MassChrom® Steroids in Serum/Plasma - LC-MS/MS
73000 – MassChrom® Cortisol, Cortisone in Saliva - LC-MS/MS
75111 – MassChrom® Amino Acid Analysis in Plasma/Serum - LC-MS/MS
75222 – MassChrom® Amino Acid Analysis in Urine - LC-MS/MS
80600 – Sample Prep Set Catecholamines, free Metanephrines, Serotonin
80700 – Sample Prep Set Total Metanephrines (free + conjugated)
80800 – Sample Prep Set VMA, HVA, 5-HIAA
81000 – MassChrom® Free Metanephrines in Plasma
87000 – MassChrom® Vitamins B1 and B6 in Whole Blood
92111 – Basic Kit A for TDM Series A
92711 – Basic Kit A for TDM Series A for MassSTAR
92712/XT – Parameter Set Neuroleptics 1/EXTENDED for MassSTAR
92713/XT – Parameter Set Antidepressants 1/EXTENDED for MassSTAR
92714/XT2 – Parameter Set Neuroleptics 2/EXTENDED 2 for MassSTAR
92715/XT – Parameter Set Antidepressants 2/ Psychostimulants/EXTENDED for MassSTAR
92716 – Parameter Set Mycophenolic Acid for MassSTAR
92721/XT – Parameter Set Antiepileptic Drugs All-in-One Method for MassSTAR
92722/XT – Parameter Set Antimycotic Drugs/EXTENDED for MassSTAR
92912/XT – Parameter Set Neuroleptics 1/EXTENDED - LC-MS/MS
92913/XT – Parameter Set Antidepressants 1/EXTENDED - LC-MS/MS
92914/XT2 – Parameter Set Neuroleptics 2/EXTENDED 2 - LC-MS/MS
92915/XT – Parameter Set Antidepressants 2/ Psychostimulants/EXTENDED - LC-MS/MS
92916 – Parameter Set Mycophenolic Acid - LC-MS/MS
92917 – Parameter Set Benzodiazepines 1 - LC-MS/MS
92918 – Parameter Set Benzodiazepines 2 - LC-MS/MS
92919 – Parameter Set Tricyclic Antidepressants TCA 1 -LC-MS/MS
92920 – Parameter Set Tricyclic Antidepressants TCA 2 - LC-MS/MS
92921 – Parameter Set Antiepileptic Drugs - LC-MS/MS
92921/XT – Parameter Set Antiepileptic Drugs All-in-One Method - LC-MS/MS
92922/XT – Parameter Set Antimycotic Drugs/EXTENDED - LC-MS/MS
92923 – Parameter Set Antiarrhythmic Drugs - LC-MS/MS
92924 – Parameter Set Anti-HIV Drugs - LC-MS/MS
93000, 93900 – MassTox® Immunosuppressants in Whole Blood - LC-MS/MS
96000 – MassTox® Drugs of Abuse Testing in Urine