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 SALSA 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 SALSA Sample DNA (more information)
Product Code Product Type CE in Combination with Probemix
SD022CE SALSA Binning DNA P043-E; P378-D
SD031CE SALSA Binning DNA P140-C
SD052CE SALSA Binning DNA P003-D
SD067CE SALSA Binning DNA P045-C1; P056-D1
SD072CE SALSA Reference Selection DNA P008-C1

CE marked SALSA MLPA probemixes
Product NameApplicationRegion
P002-BRCA1CE Hereditary breast cancer (BRCA1) BRCA1 17q21.31
P003-MLH1/MSH2CE Lynch Syndrome MLH1 3p22.2, MSH2 2p21
P008-PMS2CE Lynch Syndrome PMS2 7p22
P015-MECP2CE RETT syndrome MECP2, Xq28
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
P043-APCCE Hereditary Polyposis Colon Cancer APC, 5q21-q22
P045-BRCA2/CHEK2CE Breast cancer, hereditary BRCA2, CHEK2
P055-PAHCE Phenylketonuria PAH 12q23.2
P056-TP53CEimproved Li-Fraumeni syndrome (LFS) and tumour analysis TP53 17p13.1
P060-SMACE Spinal Muscular Atrophy (SMA) SMN1, SMN2, 5q13
P062-LDLRCE Hypercholesterolemia, familial LDLR 19p13.2
P064-Microdeletion Syndromes1BCE Intellectual Disability; 1p-deletion, Williams, Smith-Magenis, Miller-Dieker, DiGeorge, Prader-Willi, Alagille, Saethre-Chotzen, Sotos Various
P065-Marfan Syndrome-1CE Marfan syndrome FBN1 15q21.1, TGFBR2 3p24.1
P066-Marfan Syndrome-2CE Marfan syndrome FBN1 15q21.1
P070-Subtelomeres Mix 2BCE Subtelomeric testing All subtelomeres
P077-BRCA2 ConfirmationCE Breast cancer, hereditary BRCA2
P081-NF1 mix 1CE Neurofibromatosis NF1 17q11.2
P082-NF1 mix 2CE Neurofibromatosis NF1 17q11.2
P083-CDH1CE Hereditary diffuse gastric cancer CDH1 at 16q22.1
P087-BRCA1 ConfirmationCE Breast cancer, hereditary BRCA1
P090-BRCA2CE Breast cancer, hereditary BRCA2 13q13.1
P091-CFTRCE Cystic Fibrosis CFTR 7q31.2
P093-HHT/HPAHCE Hereditary Hemorrhagic Telangiectasia (HHT), Heritable Pulmonary Arterial Hypertension (HPAH) ENG 9q34.11, ACVRL1 12q13.3, BMPR2 2q33.1
P095-AneuploidyCE Down syndrome, Edwards syndrome, Patau syndrome Chr. 13, 18, 21, X, Y
P101-STK11CE Peutz-Jeghers syndrome (PJS) STK11 19p13.3
P124-TSC1CE Tuberous Sclerosis TSC1 9q34
P138-SLC2A1-STXBP1CE GLUT1 deficiency syndrome; STXBP1 Encephalopathy with epilepsy; Ohtahara syndrome SLC2A1, 1p34.2; STXBP1, 9q34.1
P140-HBACE Thalassemias, Alpha HBA 16p
P159-GLACE Fabry Disease GLA Xq22
P189-CDKL5/ARX/FOXG1CE RETT syndrome, atypical CDKL5 Xp22.13, NTNG1 1p13.3, ARX Xp21.3
P226-SDHCE Paragangliomas (PGL) SDHD 11q23.1, SDHB 1p36.1, SDHC 1q23.3, SDHAF1 19q13, SDHAF2 11q12
P241-MODY Mix 1CE Maturity-Onset Diabetes of the Young (MODY) MODY 1, 2, 3; 5
P245-Microdeletion Syndromes1ACE Microdeletion syndromes Various
P250-DiGeorgeCE DiGeorge syndrome 22q11
P260-PALB2-RAD50-RAD51C-RAD51DCE Hereditary predisposition to Cancer 5q31, 16p12, 17q12, 17q22
P378-MUTYHCE Colon cancer, stomach cancer (hereditary) 1p34 and 15q13
P405-CMT1CE Charcot Marie Tooth Disease CMT/HNPP region at 17p12
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