CE-Marked Products (IVD)
The products specified below are CE marked for In Vitro Diagnostic (IVD) use when:

  1. used in the countries specified in the relevant product descriptions, and
  2. used in combination with each other, if applicable.

CE marked SALSA® Melt Assays 
Product Code Product Name
MC002CE SALSA MC002 SMA Newborn Screen

CE marked SALSA® MLPA® 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 for MLPA (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; P051-D2; P052-D2; P056-D1; P102-D1
SD072CE SALSA Reference Selection DNA P008-C1
SD078CE SALSA Binning DNA P190-D1

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
P051-Parkinson mix 1CE Parkinson disease, familial PARK2 6q25.2, SNCA 4q21, Pink1, Park7 1p36
P052-Parkinson mix 2CE Parkinson disease, familial PARK2 6q25.2, UCHL1 4p14, GCH1 14q22.1, LRRK2 12q12
P055-PAHCE Phenylketonuria PAH 12q23.2
P056-TP53CE 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
P102-HBBCEimproved Thalassemia, beta-zero HBB 11p15.5
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
P190-CHEK2CEimproved Breast cancer susceptibility CHEK2 22q12, ATM, TP53
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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