Genetic testing (EMDN W0106) — medical devices

UriFind® Bladder Cancer Assay Kit

AnchorDx Medical Co.Ltd.China IVD General

SOX1-OT and HIST1H4F Methylation Real-time PCR Kit

Guangzhou Hybribio Medicine Technology Ltd.China IVD General

Xl KMT2A Ba

Metasystems Probes GmbHGermany Class C

PAX5/IGH Gene Fusion Probe Detection Kit (fluorescence in situ hybridization)

Wuhan YZY Medical Science and Technology Co., LtdChina IVD General

EVI1 (MECOM) Breakapart Probe

Cytocell, Ltd.United Kingdom Class C

XCE 12 blue

Metasystems Probes GmbHGermany Class C

CSF1R(5q32) Dual Color Break Apart Probe (fluorescence in situ hybridization)

Wuhan YZY Medical Science and Technology Co., LtdChina IVD General

Human EGFR Gene Mutation Detection Kit (PCR-Fluorescence Method)

Wuhan YZY Medical Science and Technology Co., LtdChina IVD General

TRUPCR® MPN Panel Kit

3B BlackBio Dx LimitedIndia Class C

MYD88 L265P mutation digital PCR detection kit

TargetingOne Technology (Beijing) CorporationChina IVD General

11q23.3/11q24.3 Gene Deletion Probe (fluorescence in situ hybridization)

Wuhan YZY Medical Science and Technology Co., LtdChina IVD General

TRUPCR® HPV High Risk Genotyping Kit

3B BlackBio Dx LimitedIndia Class C

SS18 (18q11) Distal - XL

Leica Biosystems Newcastle, LimitedUnited Kingdom IVD General

TRUPCR® PML-RARA Kit - Quantitative

3B BlackBio Dx LimitedIndia Class C

ZNF154 gene methylation digital PCR detection kit

TargetingOne Technology (Beijing) CorporationChina IVD General

XL del(7)(q22q31)

Metasystems Probes GmbHGermany Class C

PML-RARA digital PCR detection kit

TargetingOne Technology (Beijing) CorporationChina IVD General

Human HLA-B*1502 Gene Nucleic Acid Detection Kit (Fluorescence PCR Method)

Suzhou TianLong Biotechnology Co., Ltd.China IVD General

IHepcomf

Wuhan Ammunition Life-tech Co., Ltd.China IVD General

Lung cancer-associated gene methylation digital PCR detection kit

TargetingOne Technology (Beijing) CorporationChina IVD General

Genetic testing

Subcategories4

Devices

UriFind® Bladder Cancer Assay Kit

SOX1-OT and HIST1H4F Methylation Real-time PCR Kit

Xl KMT2A Ba

PAX5/IGH Gene Fusion Probe Detection Kit (fluorescence in situ hybridization)

EVI1 (MECOM) Breakapart Probe

XCE 12 blue

CSF1R(5q32) Dual Color Break Apart Probe (fluorescence in situ hybridization)

Human EGFR Gene Mutation Detection Kit (PCR-Fluorescence Method)

TRUPCR® MPN Panel Kit

MYD88 L265P mutation digital PCR detection kit

11q23.3/11q24.3 Gene Deletion Probe (fluorescence in situ hybridization)

TRUPCR® HPV High Risk Genotyping Kit

SS18 (18q11) Distal - XL

TRUPCR® PML-RARA Kit - Quantitative

ZNF154 gene methylation digital PCR detection kit

XL del(7)(q22q31)

PML-RARA digital PCR detection kit

Human HLA-B*1502 Gene Nucleic Acid Detection Kit (Fluorescence PCR Method)

IHepcomf

Lung cancer-associated gene methylation digital PCR detection kit