IVD-Registered Products
The products specified below are registered 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.

Hover your mouse over the orange labels for more information about IVD regions. CE: EU (candidate) member states and EFTA members; CO: Colombia; MA: Morocco; IL: Israel.

IVD-registered SALSA® Melt Assays 

Product Code Product Name
MC002CE SALSA MC002 SMA Newborn Screen

IVD-registered SALSA® MLPA® products

IVD-registered software for SALSA MLPA
Product Name Purpose
Coffalyser.NetCEIL MLPA analysis software

IVD-registered SALSA MLPA reagents
Product Code Product Name
EK1-FAMCECOMAIL SALSA MLPA reagent kit 100 rxn - FAM
EK5-FAMCECOMAIL SALSA MLPA reagent kit 500 rxn - FAM
EK20-FAMCE SALSA MLPA reagent kit 2000 rxn - FAM

IVD-registered SALSA Sample DNA for MLPA (more information)
Product Code Product Type In Combination with Probemix IVD-Registered Regions
SD022 SALSA Binning DNA P043-E; P072-D; P378-D CE
SD031 SALSA Binning DNA P140-C CECOIL
SD052 SALSA Binning DNA P003-D CEIL
SD067 SALSA Binning DNA P045-C/D CEIL
P051-D2; P052-D2; P056-D; P102-D CE
SD072 SALSA Reference Selection DNA P008-C CE
SD078 SALSA Binning DNA P190-D CE
SD082 SALSA Reference Selection DNA P021-B; P060-B2 CE

IVD-registered SALSA MLPA probemixes
Product NameApplicationRegion
P002-BRCA1CE;CO;MA;IL Breast and ovarian cancer, hereditary (HBOC) BRCA1 17q21.31
P003-MLH1/MSH2CE;MA;IL Lynch syndrome MLH1 3p22.2; MSH2 2p21
P008-PMS2CE Lynch syndrome; Constitutional MMR-deficiency syndrome (CMMR-D) PMS2 7p22.1
P015-MECP2CE RETT syndrome, classic; RETT syndrome, atypical; MECP2 duplication syndrome; X-linked intellectual disability syndrome MECP2 Xq28; CDKL5 Xp22.13; ARX Xp21.3; NTNG1 1p13.3
P016-VHLCE;MA;IL Von Hippel-Lindau syndrome VHL 3p25.3
P017-MEN1CE Multiple endocrine neoplasia type 1 (MEN1) MEN1 11q13.1
P018-SHOXCE;CO;IL Leri-Weill dyschondrosteosis (LWD); Langer mesomelic dysplasia (LMD); Idiopathic short stature (ISS) SHOX Xp22.33/Yp11.32
P021-SMACE Spinal muscular atrophy (SMA) SMN1 5q13.2; SMN2 5q13.2
P033-CMT1CE;MA;IL Charcot-Marie-Tooth neuropathy (CMT); Neuropathy with liability to pressure palsies, hereditary (HNPP) CMT/HNPP region 17p12; KIF1b 1p36
P034-DMD-1CE;CO;MA;IL Duchenne muscular dystrophy (DMD); Becker muscular dystrophy (BMD) DMD Xp21.1-p21.2
P035-DMD-2CE;CO;MA;IL Duchenne muscular dystrophy (DMD); Becker muscular dystrophy (BMD) DMD Xp21.1-p21.2
P036-Subtelomeres Mix 1CE;MA;IL Subtelomeric testing All subtelomeres
P041-ATM-1CE;MA;IL Ataxia-telangiectasia (AT); Predisposition to develop cancer, hereditary ATM 11q22.3
P042-ATM-2CE;MA;IL Ataxia-telangiectasia (AT); Predisposition to develop cancer, hereditary ATM 11q22.3
P043-APCCE;MA;IL Adenomatous polyposis, familial (FAP); MUTYH-associated polyposis (MAP); Polyposis syndrome, hereditary mixed (HMPS1) APC 5q22.2; MUTYH 1p34.1; GREM1 15q13.3
P045-BRCA2/CHEK2CE;CO;MA;IL Breast and ovarian cancer, hereditary (HBOC); Susceptibility to breast cancer; Susceptibility to other cancer types BRCA2 13q13.1; CHEK2 22q12.1
P051-Parkinson mix 1CE Parkinson disease PARK2 6q26; SNCA 4q22.1; PINK1 1p36.12; PARK7 1p36.23; ATP13A2 1p36.13; LRRK2 12q12
P052-Parkinson mix 2CE Parkinson disease PARK2 6q26; UCHL1 4p13; GCH1 14q22.2; LRRK2 12q12; ATP13A2 1p36.13
P055-PAHCE;MA Phenylketonuria (PKU) PAH 12q23.2
P056-TP53CE Li-Fraumeni syndrome (LFS); (Tumour analysis for research use only) TP53 17p13.1
P060-SMACE;CO;MA;IL Spinal muscular atrophy (SMA) SMN1 5q13.2; SMN2 5q13.2
P062-LDLRCE;IL Hypercholesterolemia, familial LDLR 19p13.2
P064-Microdeletion Syndromes1BCE;MA Microdeletion syndromes; Microduplication syndromes Various
P065-Marfan Syndrome-1CE;IL Marfan syndrome; other FBN1-related disorders; other TGFBR2-related disorders FBN1 15q21.1; TGFBR2 3p24.1
P066-Marfan Syndrome-2CE;MA;IL Marfan syndrome; other FBN1-related disorders FBN1 15q21.1
P070-Subtelomeres Mix 2BCE;MA;IL Subtelomeric testing All subtelomeres
P072-MSH6-MUTYHCE Lynch syndrome; MUTYH-associated polyposis (MAP) MSH6 2p16.3; MUTYH 1p34.1; EPCAM 2p21
P077-BRCA2 ConfirmationCE;MA Breast and ovarian cancer, hereditary (HBOC) (confirmation of P045/P090) BRCA2 13q13.1
P081-NF1 mix 1CE;MA;IL Neurofibromatosis type 1 (NF1) NF1 17q11.2
P082-NF1 mix 2CE;MA;IL Neurofibromatosis type 1 (NF1) NF1 17q11.2
P083-CDH1CE;MA;IL Diffuse gastric cancer, hereditary CDH1 16q22.1
P087-BRCA1 ConfirmationCE Breast and ovarian cancer, hereditary (HBOC) (confirmation of P002) BRCA1 17q21.31
P090-BRCA2CE;CO;MA;IL Breast and ovarian cancer, hereditary (HBOC) BRCA2 13q13.1
P091-CFTRCE;MA;IL Cystic fibrosis; Congenital absence of the vas deferens (CAVD) CFTR 7q31.2
P093-HHT/HPAHCE Hemorrhagic telangiectasia, hereditary (HHT); Heritable pulmonary arterial hypertension (HPAH) ENG 9q34.11; ACVRL1 12q13.3; BMPR2 2q33.1-q33.2
P095-AneuploidyCE;CO;MA;IL Down syndrome; Edwards syndrome; Patau syndrome; Turner syndrome; Triple X syndrome; Klinefelter syndrome; XYY syndrome Chr. 13, 18, 21, X, Y
P101-STK11CE;IL Peutz-Jeghers syndrome (PJS) STK11 19p13.3
P102-HBBCE Beta-thalassemia; Persistence of foetal haemoglobin, hereditary (HPFH); Sickle cell anaemia (SCA); Sickle cell disease (SCD) HBB 11p15.4
P124-TSC1CE Tuberous sclerosis complex (TSC) TSC1 9q34.13
P138-SLC2A1-STXBP1CE GLUT1 deficiency syndrome; STXBP1 encephalopathy with epilepsy; Ohtahara syndrome SLC2A1 1p34.2; STXBP1 9q34.1
P140-HBACE;CO;MA;IL Alpha-thalassemia HBA 16p13.3
P159-GLACE Fabry disease GLA Xq22.1
P163-GJB-WFS1-POU3F4CE;improved Hearing lossWolfram syndrome type 1 GJB3 1p34.3; WFS1 4p16.1; POU3F4 region Xq21.1, 13q12 region
P189-CDKL5/ARX/FOXG1CE RETT syndrome, atypical; X-linked infantile spasm syndrome; FOXG1 syndrome CDKL5 Xp22.13; NTNG1 1p13.3; ARX Xp21.3; FOXG1 14q12
P190-CHEK2CE Susceptibility to breast cancer; Susceptibility to other cancer types CHEK2 22q12.1; ATM 11q22.3; TP53 17p13.1
P213-HSP mix-2CE Spastic paraplegia type 31 (SPG31); Spastic paraplegia type 7 (SPG7) REEP1 2p11.2; SPG7 16q24.3
P225-PTENCE PTEN hamartoma tumor syndrome, Cowden syndrome, Bannayan-Riley-Ruvalcaba syndrome, PTEN-related proteus syndrome, Proteus-like syndrome; (Tumour analysis for research use only) PTEN 10q23.31
P226-SDHCE Paragangliomas-Pheochromocytoma syndrome, hereditary (PGL/PCC) SDHD 11q23.1; SDHB 1p36.1; SDHC 1q23.3; SDHAF1 19q13.12; SDHAF2 11q12.2
P241-MODY Mix 1CE;MA Maturity-onset diabetes of the young (MODY) type 1, 2, 3, 5; Renal cysts and diabetes syndrome (RCAD) HNF1A 12q24.31; HNF1B 17q12; HNF4A 20q13.12; GCK 7p13
P245-Microdeletion Syndromes1ACE;MA;IL Microdeletion syndromes; Microduplication syndromes Various
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