Mutation Detection

 

 

 

Product Status New Cat. No. Tests/kit Type PCR Instrument (stated in IFU) Applicable PCR instruments not
included in IFU


8.01.20201W010A 10 Pre-loaded Stratagene Mx3000P™, ABI 7300, ABI 7500, ABI 7900HT QuantStudio 5
8.01.20201W010B 10 Pre-loaded LightCycler480, Bio-Rad CFX96, cobas® z480
8.01.20201W010D 10 Pre-loaded SLAN-96S
8.01.20201X024E 24 Bulk
Stratagene Mx3000P™, ABI 7300, ABI 7500, ABI 7900HT,
ABI StepOnePlus, LightCycler480, Bio-Rad CFX96,
SLAN-96S
ABI 7500 fast, QuantStudio 5,
Exicycler 96
8.01.20201X024F 24 Bulk Rotor-Gene Q/6000 (72 wells)
CE marked 8.01.20213X012E 12 Bulk Stratagene Mx3000P™, ABI 7500, LightCycler480 II,
cobas® z480, SLAN-96S QuantStudio 5, QuantStudio 12 Flex
RUO 8.0120213X012F 12 Bulk Rotor-Gene Q (36 wells)
Super-ARMS® EGFR T790M
Mutation Detection Kit
CE marked 8.01.20212X024D 24 Bulk Stratagene Mx3000P™, ABI 7500, LightCycler480 II, SLAN96S QuantStudio 5
AmoyDx® EML4-ALK Fusion Gene
Detection Kit
CE marked 8.01.22001X024H 24 Bulk Stratagene Mx3000P™, ABI 7500, LightCycler480 II,
Bio-Rad CFX96, Rotor-Gene Q/6000 (72 wells), SLAN-96S
QuantStudio 5, ABI7900HT,
ABI StepOnePlus, ABI 7500 fast
8.01.23201W012A 12 Pre-loaded Stratagene Mx3000P™, ABI 7500
8.01.23201X012H 12 Bulk Stratagene Mx3000P™, ABI 7500, LightCycler480 II,
Bio-Rad CFX96, Rotor-Gene Q/6000 (72 wells), SLAN-96S
QuantStudio 5, ABI7900HT,
ABI StepOnePlus, ABI 7500 fast
8.01.24401W008A 8 Pre-loaded Stratagene Mx3000P™, ABI 7500 QuantStudio 5, ABI7900HT
8.01.24401W008B 8 Pre-loaded LightCycler480 II
8.01.24401W008D 8 Pre-loaded SLAN-96S
8.01.25501W008A 8 Pre-loaded Stratagene Mx3000P™
8.01.25501W008D 8 Pre-loaded SLAN-96S
8.01.25501W008J 8 Pre-loaded ABI 7500 QuantStudio 5
8.01.26301W006A 6 Pre-loaded Stratagene Mx3000P™
8.01.26301W006B 6 Pre-loaded LightCycler480 II, cobas® z480
8.01.26301W006D 6 Pre-loaded SLAN-96S
8.01.26301W006J 6 Pre-loaded ABI 7500 QuantStudio 5
CE marked 8.0131202W008J 8 Pre-loaded QuantStudio 5
CE marked 8.0131202W008B 8 Pre-loaded LightCycler480 II
AmoyDx Product List
CE marked
CE marked
AmoyDx® EGFR 29 Mutations
Detection Kit
AmoyDx® ROS1 Gene Fusions
Detection Kit
AmoyDx® ALK Gene Fusions and
ROS1 Gene Fusions Detection Kit CE marked
Super-ARMS® EGFR Mutation
Detection Kit
CE marked AmoyDx® EGFR/ALK/ROS1
Mutations Detection Kit
CE marked AmoyDx® Multi-Gene Mutations
Detection Kit
AmoyDx® Pan Lung Cancer PCR
Panel
AmoyDx® MET Mutation Detection
Kit
CE marked 8.01.26101X024H 24 Bulk Stratagene Mx3000P™, ABI7500, LightCycler480 II,
SLAN-96S, Rotor-Gene Q (72 wells)
Bio-Rad CFX96, QuantStudio 5, ABI
StepOnePlus
AmoyDx® RET Gene Fusions
Detection Kit
CE marked 8.01.23301X012H 12 Bulk Stratagene Mx3000P™, ABI 7500, LightCycler480 II,
Bio-Rad CFX96, Rotor-Gene Q/6000 (72 wells)
ABI7900HT, ABI StepOnePlus,
SLAN-96S, QuantStudio 5
AmoyDx® HER2 Mutation Detection
Kit RUO 8.01.26801X024H 24 Bulk
Stratagene Mx3000P™, ABI 7500, ABI 7900HT, ABI
StepOnePlus, LightCycler480, Bio-Rad CFX96, SLAN-96S,
Rotor-Gene Q/6000 (72 wells)
AmoyDx® NTRK Gene Fusions
Detection Kit
CE marked 8.0126001X024E 24 Bulk Stratagene Mx3000P™, ABI7500, QuantStudio 5,
LightCycler480 II, SLAN-96S
Rotor-Gene Q (72 wells),
Bio-Rad CFX96, ABI StepOnePlus
8.01.20102W006A 6 Pre-loaded Stratagene Mx3000P™, ABI 7500
8.01.20102W006B 6 Pre-loaded LightCycler480, cobas® z480
8.01.20102X024H 24 Bulk Stratagene Mx3000P™, ABI 7500, LightCycler480,
Bio-Rad CFX96, Rotor-Gene Q/6000 (72 wells), SLAN-96S
QuantStudio 5, ABI7900HT,
ABI StepOnePlus, ABI 7500 fast
8.01.25001X024H 24 Bulk Stratagene Mx3000P™, ABI 7500, LightCycler480,
Bio-Rad CFX96, Rotor-Gene Q/6000 (72 wells), SLAN-96S
QuantStudio 5, ABI7900HT,
ABI StepOnePlus
8.01.25001W008A 8 Pre-loaded Stratagene Mx3000P™, ABI 7500 QuantStudio 5
AmoyDx® BRAF V600 Mutations
Detection Kit
CE marked 8.01.20302X024E 24 Bulk Stratagene Mx3000P™, ABI 7500, ABI 7900HT, ABI
StepOnePlus, LightCycler480, Bio-Rad CFX96, SLAN-96S QuantStudio 5
8.0120303X024E 24 Bulk Stratagene Mx3000P™, SLAN-96S,
Rotor-Gene Q (72 wells) QuantStudio 5
8.0120303X024B 24 Bulk LightCycler480
8.0120303X024C 24 Bulk Bio-Rad CFX96
8.01.25402W006A 6 Pre-loaded Stratagene Mx3000P™, ABI 7500
8.01.25402W006D 6 Pre-loaded SLAN-96S
8.01.25402X024H 24 Bulk Stratagene Mx3000P™, ABI 7500, LightCycler480,
Bio-Rad CFX96, Rotor-Gene Q/6000 (72 wells), SLAN-96S
QuantStudio 5, ABI7900HT,
ABI StepOnePlus, ABI Vii 7
8.01.25403W006A 6 Pre-loaded Stratagene Mx3000P™, ABI 7500
8.01.25403W006B 6 Pre-loaded LightCycler480
8.01.25403W006D 6 Pre-loaded SLAN-96S
CE marked 8.01.21601X024E 24 Bulk Stratagene Mx3000P™, ABI 7500, LightCycler480,
Bio-Rad CFX96, SLAN-96S
ABI7900HT, ABI StepOnePlus,
QuantStudio 5
RUO 8.0121601X012F 12 Bulk Rotor-Gene Q/6000 (72 wells)
AmoyDx® PIK3CA Mutation
Detection Kit
CE marked 8.0121602X024E 24 Bulk Stratagene Mx3000P™, ABI7500, LightCycler480,
Bio-Rad CFX96, SLAN-96S QuantStudio 5, ABI StepOnePlus
CE marked 8.01.20801X024E 24 Bulk Stratagene Mx3000P™, ABI 7500, ABI 7900HT, ABI
StepOnePlus, LightCycler480, Bio-Rad CFX96
RUO 8.01.20801X024E 24 Bulk Rotor-Gene Q/6000 (72 wells)
AmoyDx® KRAS/NRAS Mutations
Detection Kit
AmoyDx® KRAS/NRAS/BRAF Mut
ations Detection Kit
AmoyDx® BRAF Mutation Detection
Kit (V2) CE marked
CE marked
CE marked
CE marked
CE marked
AmoyDx® KRAS Mutation Detection
Kit
AmoyDx® NRAS Mutation Detection
Kit
AmoyDx® PIK3CA Five Mutations
Detection Kit
AmoyDx® JAK2 Mutation Detection
Kit
8.01.27701X024B 24 Bulk ABI7500, LightCycler480 II
8.01.27701X024D 24 Bulk Stratagene Mx3000P™, SLAN-96S
AmoyDx®
Human Papillomavirus
(HPV) Genotyping Detection Kit
CE marked 8.01.25803X048E 48 Bulk Stratagene Mx3000P™, ABI 7500, LightCycler480,
SLAN-96S, Rotor-Gene Q (72 wells) Bio-Rad CFX96, QuantStudio 5
AmoyDx® High-risk Human
Papillomavirus (HPV) Detection Kit
CE marked 8.01.25802X048E 48 Bulk Stratagene Mx3000P™, ABI 7500, LightCycler480,
Bio-Rad CFX96, SLAN-96S, Rotor-Gene Q/6000 (72 wells) QuantStudio 5
AmoyDx®
SDC2 Methylation
Detection Kit
RUO 8.0131501X024D 24 Bulk Stratagene Mx3000P™, SLAN-96S
Super-ARMS® EGFR Mutation
Detection Kit - Calibration Reagent
(for color compensation)
RUO 8.01.20218X012B 12 Bulk LightCycler480
AmoyDx® Pan Lung Cancer PCR
Panel - Calibration Reagent
(for color compensation)
RUO 8.0131202X012B 12 Bulk LightCycler480
AmoyDx® BRCA1 and BRCA2 Gene
Mutation Detection Kit (Reversible
Terminator Sequencing)
CE marked 8.06.27203X024I 24 Bulk Illumina NovaSeq 6000, NextSeq 500, MiSeq, MiSeq Dx,
MiniSeq, iSeq 100
AmoyDx®
Essential NGS Panel CE marked 8.06.27401X024I 24 Bulk Illumina NextSeq 500, MiSeq
AmoyDx® HANDLE Classic NGS
Panel
CE marked 8.0680601X024I 24 Bulk Illumina NextSeq 500, MiSeq, MiniSeq
AmoyDx® HANDLE HRR NGS Panel CE marked 8.0680701X024I 24 Bulk Illumina NovaSeq 6000, NextSeq 500, MiSeq, MiSeq Dx,
MiniSeq, iSeq 100
AmoyDx® HRD Focus Panel CE marked 8.0683101X024I 20 Bulk Illumina NovaSeq 6000, NextSeq 500
AmoyDx® Comprehensive Panel RUO 8.0682501X024I 24 Bulk Illumina NovaSeq 6000, NextSeq 500
Enzymatic Fragmentation Kit RUO 8.0681201X024I 24 Bulk /
ANDAS Data Analyzer CE marked 8.06.30501W001I / / /
AmoyDx® HER-2 Gene
Amplification Analysis Kit
CE marked 8.03.25101X020G 20 Bulk /
AmoyDx® FFPE DNA Kit CE marked 8.02.23501X036G 36 Bulk /
AmoyDx® FFPE DNA Kit RUO 8.0223503X036G 36 Bulk Note: downstream DNA used for HRD testing only.
AmoyDx® FFPE RNA Kit CE marked 8.02.24101X036G 36 Bulk /
AmoyDx® FFPE DNA/RNA Kit CE marked 8.02.23601X036G 36 Bulk /
RUO AmoyDx® TERT/HRAS Mutations
Detection Kit
AmoyDx
®
Blood/Bone Marrow DNA
Kit
RUO 8.02.24201X036G 36 Bulk
/
AmoyDx
® Circulating DNA Kit CE marked 8.02.26201X024G 24 Bulk
/
AmoyDx
® Tissue DNA Kit RUO 8.02.24301X036G 36 Bulk
/
AmoyDx
® Tissue RNA Kit RUO 8.02.24601X036G 36 Bulk
/
AmoyDx
® Stool BisDNA Kit RUO 8.0250101X012G 12 Bulk
/
AmoyDx
®
Stool Specimen
Preservation Solution
RUO 8.0250201X012G 12 Bulk
/
AmoyDx
® Cell-free DNA Protection
Vacuum Tube
RUO 8.04.26401X010G 10
/
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