CE marked products (IVD)
The MLPA probemixes, reagents and software specified below are CE marked for In Vitro Diagnostic (IVD) use when:

  1. used in combination with each other, and
  2. used in the countries specified in the product descriptions of the corresponding products.

CE marked software
Coffalyser.Net MLPA analysis software is CE marked.

CE marked MLPA reagents
Product Code Product Name
EK1-FAMCE SALSA MLPA reagent kit 100 rxn - FAM
EK5-FAMCE SALSA MLPA reagent kit 500 rxn - FAM

CE marked MLPA probemixes
Product NameApplicationRegion
P002-BRCA1CE Hereditary breast cancer (BRCA1) BRCA1 17q21.31
P003-MLH1/MSH2CE Lynch Syndrome MLH1 3p22.2, MSH2 2p21
P016-VHLCE Von Hippel-Lindau Syndrome VHL, 3p25
P018-SHOXCE Idiopathic growth retardation SHOX-Xp22
P033-CMT1CE Charcot-Marie Tooth disease (CMT1), Hereditary Neuropathy with liability to Pressure Palsies (HNPP) CMT1/HNPP region, 17p12
P034-DMD-1CE Duchenne Muscular Dystrophy (DMD) DMD, Xp21.2
P035-DMD-2CE Duchenne Muscular Dystrophy (DMD) DMD, Xp21.2
P036-Subtelomeres Mix 1CE Subtelomeric testing All subtelomeres
P041-ATM-1CE Ataxia-Telangiectasia (AT) ATM 11q23
P042-ATM-2CE Ataxia-Telangiectasia (AT) ATM 11q23
P045-BRCA2/CHEK2CE Breast cancer, hereditary BRCA2, CHEK2
P055-PAHCE Phenylketonuria PAH 12q23.2
P060-SMACE Spinal Muscular Atrophy (SMA) SMN1, SMN2, 5q13
P062-LDLRCE Hypercholesterolemia, familial LDLR 19p13.2
P069-Subtelomeres Mix 2ACE Subtelomeric testing All subtelomeres
P070-Subtelomeres Mix 2BCE Subtelomeric testing All subtelomeres
P090-BRCA2CE Breast cancer, hereditary BRCA2 13q13.1
P091-CFTRCE Cystic Fibrosis CFTR 7q31.2
P095-AneuploidyCE Down syndrome, Edwards syndrome, Patau syndrome Chr. 13, 18, 21, X, Y
P101-STK11CEimproved Peutz-Jeghers syndrome (PJS) STK11 19p13.3
P140-HBACE Thalassemias, Alpha HBA 16p
P245-Microdeletion Syndromes1ACE Microdeletion syndromes Various
P250-DiGeorgeCE DiGeorge syndrome 22q11
P405-CMT1CE Charcot Marie Tooth Disease CMT/HNPP region at 17p12
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